InRatio 2 strip rrecall - important

[Protimenow]

Alere just issued a voluntary recall on its InRatio 2 strips. According to the company, the results were reported as lower than the laboratory results 'by a range of 3.1 - 12.2 INR units' and there were reports of three associated patient deaths.

The company said that it is 'concerned that the ....Test stips may report an inaccurately low INR result.' They advise their customers to 'immediately STOP using the InRatio2 Professional Test Strip (PN 99008G2) and use an alternative method to perform PT/INR testing'.


This is scary stuff.

Check your strip item number (probably on each foil strip pouch and, if the part number is a match, DON'T USE IT. You should be able to return these strips to your source for the strips (but, of course, each EBay seller may have its own policies, if you bought your strips on eBay). This also probably only applies to the 'new, improved' strips.

If I can figure out how to attach the recall PDF, I would have done so.

 

[dick0236]

Thanks for the heads up. There is a "PN" number on each foil wrapped pack. The number on my current packs is 28227 Rev. A. This is my first lot of the new strips and so far, they are testing almost identical to my docs Coaguchek XS meter/strips (two tests). Seems strange that the recall is for a "PN" number and not the Lot # or strip code.

 

[Protimenow]

Dick -- the recall notice gives a PN - perhaps ALL InRatio 2 strips are the same 'part,' so they have the same number.

Alere is, of course, being very cautious. The problem might be occurring in one out of 10,000 tests, for all I know. With three deaths possibly related to the strips, it makes sense to be extremely cautious. The variation between InRatio 2 results and lab results is scary. I stopped using my InRatio and InRatio 2 before the new strips came out.

I don't know if the problems that caused the recall were related to specific lot numbers or, perhaps, to meters that didn't work properly with the new strips.

I'm glad to hear that your results and your doctor's results using an XS are close. (Are you using the new InRatio 2 strips?).

 

[dick0236]

I'm glad to hear that your results and your doctor's results using an XS are close. (Are you using the new InRatio 2 strips?).

Yes, I started using the new strips a couple months ago. However, the PN #28227 Rev.A of my current strips is very different from the one you list in your post.

Out of curiosity I checked the meter I bought about two years ago, thinking the recall might be for a meter. The PN for my meter is PN:28184 Rev A which is close to the PN for my strips. I am wondering what the recall PN(99008G2) is referring to.

 

[newmitral]

I went to the Alere website to read the info on the recall.

It seems that home testing patients should not be effected by this. The "professional" test strips are evidently different from the home-test unit strips.

The following is a quote from the Alere FAQ
http://www.inr-care.com/ww/index/faqs.html
about the recall:

I have patients enrolled with your service through Alere Home Monitoring. Do they have this product in use for their home monitoring?

No, the AHM Patient Self Testers have been using the Alere INRatio® PT/INR Test Strip (PN 100071) and will remain with this product. The Alere INRatio®2 PT/INR Professional Test Strip (PN 99008G2) has not been introduced for use in this market.

If you should have any questions, please do not hesitate to call Alere Home Monitoring to inquire about the product at 1.877.262.4669 option 1

The full story can be found on the Alere website at:
http://www.inr-care.com/ww/index/customer-information.html

 

[Protimenow]

I'm not sure whether or not the InRatio 2 test strips are ALL called 'Professional Test Strips' or not. It may be worth a call to Alere to find out whether or not the InRatio 2 Test Strips used by self-testers are the same as the 'Professional' test strips. I'm concerned that 'gray market' vendors who sell on eBay or Amazon may be selling the 'Professional' strips. I'm also concerned whether or not there IS a difference between what is sent to self-testers and what goes to MDs.

 

[Protimenow]

I just saw an image of the strips on eBay -- there is a Part Number on the foil package for each strip, right above the pink (maroon?) storage indications (thermometer). The ones that I saw for sale had a different PN. It certainly wouldn't hurt to check your batch, just in case the PNs match those in the recall.

 

[RobThatsMe]

Just got back on line after the Easter weekend. Thanks for the heads-up!
All is ok here, my strips are not effected.

 

[donnag131]

Dick, my foil packet also has PN:28227 on it. This is not the PN they are referring to. If you still have the original box that they came in, look on the side of the box. If there is the word REF with a box around it and the numbers 99008G2 following it, then these are the recalled strips. They are the newer strips with the bigger blood drop space. I have no idea why the number is not on the actual strip foil pouch.

newmitral, I am a home tester, and I have been affected by the recall. Alere was referring to people in THEIR home-testing program.

I have been purchasing my strips for years through Imperial Surgical Supply out of NY. $185 for a 48 count box. The last batch I ordered a few weeks ago happened to be the recalled ones. I'm glad to have read about the recall here, since they never informed me of it. When I contacted them, they said they were aware of the recall, but had no different strips to send me to replace them. I called Alere and they wanted to charge me $165 for 12! I refuse to be a client of theirs with that weekly call-in program they have. It's cheaper for me to pay out of pocket then rely on my insurance company and Alere's almost 4x price mark-up. Anybody know of a cheaper reputable place to order strips??

UPDATE:
4 weeks ago, When I contacted Imperial Surgical Supply about the recall, the owner told me it was only a VOLUNTARY recall, and that they had no replacement strips to send me. I continued using the recalled strips, along with having both a venipuncture at the lab AND a fingerstick using a non-recalled strip within 15 minutes of each other, just to compare results out of curiosity. Three times the results were comparable. But one time the recalled strip was 0.9 HIGHER than the venipuncture and non-recalled strip.

Also, about 3 weeks after I first called Imperial Surgical Supply about the recall, they finally contacted me and said they would send me a new box of strips, but that I had to send them back all unused recalled strips immediately because Alere was requiring ALL unused strips back.

 

[dick0236]

Dick, my foil packet also has PN:28227 on it. This is not the PN they are referring to. If you still have the original box that they came in, look on the side of the box. If there is the word REF with a box around it and the numbers 99008G2 following it, then these are the recalled strips. They are the newer strips with the bigger blood drop space. I have no idea why the number is not on the actual strip foil pouch.
??

I contacted the supplier I got my strips from and they asked if my foil strip package had a green stripe at the top (mine do) and if so, those are the recalled strips. I got the impression that the recall applied to ALL of the new design strips. They suggested using the older strips, not the new design or go to my doc for testing until Alere can correct the problem. My supplier will refund my cost of my unused strips but can't replace them as they do not have any of the old strips. I called Alere and received no help and was told I shouldn't have bought illegal strips from Ebay in the first place. I think I'll buy a Coaguchek.

 

[newmitral]

.......

newmitral, I am a home tester, and I have been affected by the recall. Alere was referring to people in THEIR home-testing program.

...... Anybody know of a cheaper reputable place to order strips??

Hello donnag131,

Thanks for the info - I may have given Alere too much credit when I read their explanation of the recall.

I am still not sure if all the new design strips are effected, particularly since I compared the new strips against the old on two separate meters back in November (see thread here )
http://www.valvereplacement.org/forums/showthread.php?42262-INRatio-strips-from-different-lots
and the new design strips agreed to within +/-0.1 of the old strips on two different meters.

Nevertheless, I just ordered a box of 12 strips of the old design from Amazon ($74.95) which is slightly above the price I paid on ebay for my last batch of the new design strips. I should receive them by Friday, so I'll be able to say for certain if they are indeed the old design strips, and will do a new comparison against my remaining new design strips on Saturday (my normal weekly test day)

I'm not ready to buy a Coaguchek-XS just yet, but if I can't get good test strips for the Inratio2 I may join Dick in trying that alternative.

 

[dick0236]

,
.......I am still not sure if all the new design strips are effected, particularly since I compared the new strips against the old on two separate meters back in November.

I'm confused too. I have to go in to my docs office monthly for an INR test(his requirement) even tho I test weekly at home. I routinely home test on the same day I go to his INR lab just to check my meter(INRatio2) against theirs(CoaguchekXS). My last two monthly "stics" using my new design strips against docs Coaguchek strips have been within +/-.2 and I thought I was OK.....but now I am not sure. The Alere tech told me that not all of the new strips are defective, but they are unsure as to which ones are bad, so they recalled them all. I also got the impression from him that the new design was supposed to be used by doctors INR labs only and not individual testers. I think I'll put my meter away until Alere gets this mess sorted out.

 

[Protimenow]

n the world of medical testing with meters, he manufacturers of the meters or strips seem to be extremely careful about making sure that no errors are permitted. This is the reason they put lot numbers on these at all -- if a problem occurs, they can identify the offenders and recall them. Excess caution is certainly preferable (from a manufacturer's viewpoint) to an outright ban on a particular meter, or some major fines from the FDA, or some lawsuits relating to unnecessary deaths.

That said, I reported some suspected errors with my ProTime strips a few years ago - and a few months later, the batch of strips was recalled. The company that sold them to me went out of its way to make sure that I was contacted and that I returned the 'defective' strips.

I'm kind of surprised that Alere didn't fall all over themselves if ANY of their strips may have been identified as possibly inaccurate. Until they can isolate the serial numbers of the lots of strips that have the error, rather than just a broad part number, they may have a problem. Perhaps what they wanted people to be aware of is that these new strips, in general, in their current incarnation, should not necessarily be trusted for accuracy. They may not want to recall ALL their InRatio 2 strips because a few may be defective. Blaming their customers for buying these possibly defective strips from the wrong supplier is a pretty appalling attempt at shifting the blame -- if the strips are no good, what does it matter WHERE you got them? If you have a hemorrhagic event, is it YOUR fault that you bought their defective strips from the wrong supplier? What are they thinking.

FWIW - I no longer use my InRatio or InRatio 2. In fact, I let a box of perfectly good InRatio strips expire because I stopped trusting my meter's accuracy (at least, with my blood chemistry).

---

As I've noted on other threads, my go to meter is the Coag-Sense, which usually reports at or slightly below the lab results -- so if it reports from 2.0 - 3.3, I feel that I'm comfortably in range. My next meter of choice is the CoaguChek XS -- which is also pretty close to labs, but often reports somewhat higher than the labs (and I'd rather have a meter that reports slightly low, so that I can be comfortable that my INR is above 2.0). My XS strips have expired, and I'm not sure about getting a new batch.

Getting back to the subject of this thread - the recall of InRatio 2 strips; from what others have said, it's ALL the new strips that MAY be prone to this error -- I don't personally think that you have to scrap or try to return a supply of these strips, but DO assure that these compare closely to actual blood draws (or, failing that, to a test with another meter). The error reported was a SIGNIFICANT underreporting of INR -- for example, a 2.5 with these strips may be as high as 8 or more at a lab. This should be fairly easy to rule out with a test or two and a comparison to the lab.

 

[newmitral]

I received my "old-design" Inratio2 test strips yesterday and did a comparison test this morning with the "new-design" test strips I already had.

The results are:
New Design Strip - INR=2.7
Old Design Strip - INR=2.5

For me, this is close enough that I conclude that my specific batch of new design strips is OK, and I will continue to use them. This decision is purely my own, and I'm not advocating that others use recalled test strips. My confidence in my specific lot of new design test strips is enhanced by the fact that the test result is slightly higher with the new design test strip than with the old design, and the recall is based on the defective new design test strips reading unacceptably low - clearly not the case with my batch of strips.

However, the thing that really bothers me is that both the old and the new test strip foil packages carry the exact same part number:
PN: 28227 Rev. A

This is one of the most absurdly stupid things any manufacturer can do - give the same exact part number (including Revision Code) to two different design parts. This decision alone should get someone at Alere fired. I do agree with "Protimenow" that Alere's attitude towards users who purchase strips from other suppliers is misguided, and they may be liable regardless of where defective strips were purchased. The fact that users can't tell from the part number on the strips, which is evidently different from the part number on the box of 48 strips, throws Alere's entire quality control methods into question as far as I'm concerned.

I may eventually switch over to a Coaguchek-XS after all, although I do like the fact that the Inratio2 test strips don't need the separate code chip. Also, can any Coaguchek users confirm whether the Coaguchek test strips should (or need to) be kept refrigerated or not?

Thanks.

 

[Protimenow]

A few answers/thoughts.

Regarding the storage temperatures for the CoaguChek XS strips -- I checked with Roche last year, when we were having 100+ degree days here in Southern California, and they told me that the strips are okay. (It probably isn't a bad idea, nonetheless, to keep them in a refrigerator on really hot days -- but be sure not to freeze them).

Quality control for the InRatio strips probably comes down to lot number on the strips and box that they came in, rather than the part number. This way, they can probably identify the defective lot and recall ONLY the strips that are affected. It's surprising that Alere identified the questionable strips using a part number, rather than a range of lot numbers.

I suspect that if you got your strips recently, they were probably good, having been supplied to your source as a replacement for the suspicious strips.

It DOES seem as if your new strips will provide results that approximate the old values.

(My personal testing of the InRatio yielded results that were higher than the labs -- in some cases, perhaps dangerously high. I have STOPPED using my InRatio because I no longer trust the results.)

 

[Freddie]

My instructor told me, 'that you do not need refrigerate the CoaguChek XS test strips'.

PTN may think it's a good idea to put them in the refrigerator on hot days, problem with that is on hot days your refrigerator runs longer and more often, which in turn makes items somewhat colder. I also think that your sample would gel up and not be able to be drawn into the test strip.

Humidity, and leaving the cap off the test strip container will damage the strips. At least three times in the instruction manual is says, 'remove test strip and replace cap'.

 

[pellicle]

Hi

My instructor told me, 'that you do not need refrigerate the CoaguChek XS test strips'.

I agree, especially if you live in a place where "room temperature" is a phrase that has any meaning. In my apartment in Finland its 21C 90% of the time, same too for my friends house in Alberta Canada. However in my house in Tropical Australia its not uncommon for it to get to 38C inside

Roche themselves say:

Storing the Test Strips
Store the test strips in their original container, with the cap tightly closed. You can store the test strips at room temperature or in the refrigerator (2 to 30 °C or 36 to 86 °F). When stored properly, the test strips can be used until the expiration date printed on the test strip container.

From my habits in film chemistry and my lab training in in my biochem days stability of temperature is paramount. In my house the daily range can be from 18 to 38 in summer (yes, on any given day). As there are also readers of this forum from outside the USA (Malaysia has popped up as too has Qatar) it would seem prudent to store in a fridge (which does not freeze).

I have found that the "butter compartment" does not go lower than 5 (even when my lettuce freezes at the bottom in the crisper).

If storing in the fridge I strongly recommend you pull the container out and let it attain room temperature before opening it. If you open it cold then you will get condensation of some sort (even if you can't see it). I can assure you that when loading sheets of 4x5 into my film holders I just can't get the buggers in if I have failed to allow them to reach room temp before opening the sealed box from the freezer (film I freeze). They absorb moisture fast and swell and the emulsion on the edges gets sticky ... I'm expect that this has some effect on the strips too.

 

[Protimenow]

It should be clear, from the instructions provided by Roche, that these strips should not be exposed to air / humidity for very long. That's why they insist that you put the cap back on as soon as possible after opening the tube. It's probably why they pack these strips in tubes of 6 strips each (although it's possible that they also sell tubes with 24 strips). If you store them in the refrigerator, it's probably not a bad idea to add a second layer of protection by putting the tube into a Ziploc (or similar) bag and squeezing the air out. The idea of letting the strips come to (or close to) room temperature after removing them from the refrigerator is also a good idea.

Although the XS heats the strip to body temperature, you won't have to wait as long for the meter to be ready to take that drop of blood if it's not heating up a strip that's near refrigerator temperature.

 

[pellicle]

Hi

It's probably why they pack these strips in tubes of 6 strips each (although it's possible that they also sell tubes with 24 strips).

not only possible, its what I normally buy ... same size tube.

Its worth noting that in the lid of the tube there is a compartment which is filled with desiccant. I have removed and cleaned this out and then reused the tubes to carry liquids when hiking (like cooking oil, soy sauce, juice concentrate), the tubes are actually quite water tight.

...it's probably not a bad idea to add a second layer of protection by putting the tube into a Ziploc (or similar) bag and squeezing the air out.

I've actually done a bit of testing with ziploc bags and they do eventually allow air humidity in even though they appear sealed. I have tried them in the past with 'indicator silica gel' to store lenses and found it to be quite unsatisfactory in terms of humidity protection. It was less than a month.

I have repeated this experiment a few times over the years, but the last time I wrote up the data and published was on my blog:

http://cjeastwd.blogspot.com/2008/04/humidity-and-cameras.html

essentially the ziploc bags allow enough moisture in to deplete a sizable amount of silica gel in a relatively short time (significantly more than in the caps of the tubes) and so my view is that the addition of the bags would do little to assist the issue.

The fridge is however much lower humidity (stick a hygrometer in and measure it), especially in summer where its frequently 99% in my house.

 

[Protimenow]

Your comments about Ziploc bags are certainly relevant. I'm sorry that I mentioned them. In some cases, I've also found that they let air in from the seam at the side of the 'zipper.'

However, I've found a ZipLoc product that works MUCH better than the generic Ziploc bag -- these are the ZipLoc bags designed for SousVide, or for vacuum sealing. There's a kit that comes with a supply of quart-sized bags and a hand pump. The pump pulls the air out of the bag and creates a vacuum. I've been using these for cooking in my Sous vide oven for quite a while. I've been using these to seal any foods that I want air tight -- I showed this to a friend, and the friend used it to squeeze the air out of a bag of coffee beens or ground coffee, and the friend took the bag, coffee and pump along on a trip.

There may be some risk storing foods at room temperature in a vacuum sealed bag (Pellicle - I'm sure that you know ALL ABOUT anaerobic bacteria), but for things that should be kept away from humidity and, in the case of CoaguChek XS strips, relatively air tight, the ZipLoc vacuum seal bags are probably idea.