InRatio 2 strip rrecall - important

[newmitral]

Thanks to all who replied regarding the Coaguchek-XS strip refrigeration requirements.
As long as they can be stored at room temperature, this would be OK. I thought that I had read they required refrigeration, but evidently this was a mistaken impression on my part. Except for a week in July a few years ago when my central air conditioner conked-out, my home's normal room temperature range would keep them safely within their required storage temperature range limits. The humidity sensitivity along with the shared container is a bit of a concern. In this respect, the Inratio2 strips have an advantage since they are each hermetically sealed within their own individual foil packages.

I'll have to weigh the pros and cons of each system a bit more before making a decision about switching systems.

Thanks again.

 

[pellicle]

Hi

Your comments about Ziploc bags are certainly relevant. I'm sorry that I mentioned them.

I hope you didn't feel that I was bashing you on that point. I'm sorry if that is how it came across. I just dumped data out to support my view as I don't like the "my mum makes better biscuits than your mum" style of discussion.

(Pellicle - I'm sure that you know ALL ABOUT anaerobic bacteria)

certainly close to my heart that's for sure. My chest wound is still 'grumbly' in terms not feeling settled and I approach the time when I cease the antibiotics (next month actually). We shall see if its just difficult scar tissue (from the rough debridment) or if something lurks there ...

 

[pellicle]

Hi

I'll have to weigh the pros and cons of each system a bit more before making a decision about switching systems.

when weighing the pros and cons I would ignore the issues of perception of strip 'sealing' against weather. If Roche have a use by date on them and say what they do then I'm pretty sure that (given all the attention their product receives in terms of testing) that is a non issue.

I would evaluate your product choices on such points as:
* confidence in their accuracy
* price of consumables
* ease of availability of the consumable

I'm very happy with the Coacuchek, the XS is a 3rd generation system using electrochemical INR detection (not mechanical, and is the current methodology used in the lab machines like i-Stat), I'd check what the INRatio is (as I don't know and don't have one).

Best Wishes

 

[Protimenow]

Pellicle: No, I didn't take your comments about Ziploc (style) bags to be any kind of insult. I've noticed, on occasion, that the bags (especially the generic ones) aren't necessarily air or moisture tight.

I primarily use the Coag-Sense meter -- it's the one that I have the most faith in (in part because I would rather have a meter, like this one, that reports SLIGHTLY lower than lab results than have one that sometimes reports HIGHER. In other words, I'd feel more comfortable with a 2.0 on my Coag-Sense (with a lab value of, perhaps 2.3) than a 2.0 on a CoaguChek XS (with a lab value of maybe 1.8) or an InRatio (with a possible lab value maybe as low as 1.6 or 1.7. The CEO at Coag-Sense told me that, even though the strips are supposed to be stored below 90 degrees, storage for a week or two at temperatures in the low 100s should be okay.

(FWIW - I have a doctor friend who is taking warfarin. I had assumed that he was using a CoaguChek XS, because he told me that he uses a CoaguChek meter. From a recent conversation with him, it sounds as if he's using one of the ORIGINAL CoaguChek meters, and is apparently able to get strips for the old, Pre-CoaguChek S meter that he's using.)

 

[gerrychuck]

There seems to be a lot of confusion as to which strips are affected by this recall. It is fairly clear in the recall document I read (sent to me by Amazon, where I bought my last box of strips) that it is only the InRatio2 Professional strips that are affected; they state clearly that the InRatio PN 100071 strips are not affected, and that those returning the affected strips will be "transitioned" to InRatio PN 100139 strips. I don't know what the difference is between the 100071 and the 100139 strips, but I do know that my strips are the latter. Some of the confusion arises because Alere has numbers all over their packaging; I found the 100139 number not as "PN" but as "Ref". Otherwise there is no number on my packaging that aligns with any of the numbers discussed. So...look for "Ref" and see what number you have if you have concerns. The important thing is that neither the 100071 or the 100139 versions of the strips are affected by this recall, and those are what the vast majority of home testers apparently have. I have crosschecked my latest batch with a lab blood draw and am satisfied the results are accurate, so I am going to continue to use my InRatio 2 meter and use up my strips.

 

[Marty]

Test Strip Problem

Test Strip Problem

There seems to be a lot of confusion as to which strips are affected by this recall. It is fairly clear in the recall document I read (sent to me by Amazon, where I bought my last box of strips) that it is only the InRatio2 Professional strips that are affected; they state clearly that the InRatio PN 100071 strips are not affected, and that those returning the affected strips will be "transitioned" to InRatio PN 100139 strips. I don't know what the difference is between the 100071 and the 100139 strips, but I do know that my strips are the latter. Some of the confusion arises because Alere has numbers all over their packaging; I found the 100139 number not as "PN" but as "Ref". Otherwise there is no number on my packaging that aligns with any of the numbers discussed. So...look for "Ref" and see what number you have if you have concerns. The important thing is that neither the 100071 or the 100139 versions of the strips are affected by this recall, and those are what the vast majority of home testers apparently have. I have crosschecked my latest batch with a lab blood draw and am satisfied the results are accurate, so I am going to continue to use my InRatio 2 meter and use up my strips.

I received a new box of test strips from Amazon April 30 which they obtained from Tops Medical Supply-48 strips for $199.No where on the box or strips do I see INRatio2 I called Alere tech and gave them the lot# and PN# and the REF 0100139, no green stripe and the tech said these strips were probably not in the call back. I think tomorrow I will test myself twice once with one of the old strips and once with the new.
I will report the results

 

[Marty]

Results this AM 5-11-14 old strip ref 0100139 2014-06 INR 3.4, new strip ref 0100139 2014/11 INR 3.2 Both boxes obtained from Amazon but different sellers.

 

[chaconne]

Update on testing with New InRatio2 Professional (with green stripes):

I've got these strips and they seem to work for me, or at least agree with lab draws. I've had 4 comparison tests with lab draws and they all agreed to within 0.2 except for one that the strips measured 0.6 higher (3.3 vs. 2.7). For this outlier, I did my InRatio test an hour after I had a lab draw in the evening, rather than doing my InRatio test in the morning and then getting a lab test an hour later like I've always done before. I got these strips from Ebay in a 24-pack.

 

[gerrychuck]

Where are people getting their new INRatio strips now? I need to reorder, and they seem to have virtually disappeared from ebay (only one listing I can find) and I can't find them at all on Amazon, where I've always bought them before. Kind of odd.

 

[newmitral]

Hi gerrychuck,

It's not odd, nor unexpected. I figured this would happen once Alere announced the recall and there was no restriction on manufacturing lot number traceability of the problem. This means they have a big quality assurance problem to grapple with and the supply stream of strips will likely remain dried up for a while until they solve the problem.

I got a supply of 12 "old design" strips just after the recall was announced, and proved to my own satisfaction that my remaining "new style" strips were not defective, so at the moment I still have about 20 Inratio test strips left. However, since I think this problem may last longer than 20 weeks, my longer term solution was to purchase a used Coaguchek-XS meter from Ebay, which I got for $225, along with a box of 48 Coaguchek test strips (another $200) from another vendor. Cost for Coaguchek test strips is about the same as the cost for Inratio2 test strips was.

After parallel testing for a few weeks on both meters, I'm confident that both meters give me the same test results (+/-0.1), so I'm set to weather the storm until the Inratio2 strips return to the market.

I'm not saying my solution of grabbing a second, different brand meter will be an appropriate solution for everyone, but it worked for me. Of course, once other home-testers get into a bind with lack of Inratio2 test strips, the competition for the used Coaguchek meters will drive prices up on Ebay, so if you do want to try this option, you might want to do it sooner rather than later.

I also figure that once the Inratio2 test strips are widely available again, I can sell my unneeded meter (whichever one I like least after having used both) and recover most of my investment.

 

[gerrychuck]

Managed to buy a box of 48 Inratio strips (with the correct non-recall ref number) with an expiry of 05/15 off ebay today. Should be good for the next year. I'll follow my usual practice and do a lab cross-check when I start using the new batch.

 

[bocco]

I just looked myself and there are no strips available on Ebay or Amazon.

 

[chaconne]

bocco,

I've noticed this as well. I can believe that Alere is going to hold on much more tightly to their product and not allow distributers like Amazon and Ebay to sell the product anymore. When I called Alere for info on their strips a few months ago, they seemed upset that I had gotten mine from Amazon. Does this signal the end of un-supervised INR self-testing for us?

 

[marc_kowal]

I'm just curious why so many people are against the "supervised" self-testing. It literally takes 3 minutes to call in your results and then they forward the info to your cardiologist. If I elect to have a lab draw done that week, Alere usually calls and leaves a message that I need to call in my results (which I disregard since I had the lab draw done and the lab calls it in to my cardio). Is it more of a pricing issue for people?

 

[chaconne]

Marc,

I'm not against it, it's just not an option for me with Kaiser Permanente. They only cover lab draws for me. I need the ability to take matters into my own hands If I'm on vacation in a remote area, or overseas, and have no viable ways to check my INR. And yes, going through Alere is too expensive for me to pay out of my own pocket.

 

[pellicle]

Hi

After parallel testing for a few weeks on both meters, I'm confident that both meters give me the same test results (+/-0.1), so I'm set to weather the storm until the Inratio2 strips return to the market.

Gee, sounds like the old dilemma of letting a BMW driver drive a Mercedes, they may discover they prefer the merc and never go back

 

[pellicle]

Hi Marc

I'm just curious why so many people are against the "supervised" self-testing.
....
Is it more of a pricing issue for people?

Not having seen anyone here objecting to it I'm not sure what you mean. The main objectors seem to be medical clinics who are thus unable to bill hundreds per test and Dr's who probably don't trust their patients.

For the competent person home test in has only benefits

 

[donnag131]

"Disclaimer:
I agree that I am a physician and or a licensed home healthcare facility. I have a medical license to purchase this product."

I looked at a few different suppliers websites where I have purchased InRatio strips in the past to see if they have strips available yet. The above disclaimer, or one similar, is now on every InRatio order page. It never was before. I guess InRatio doesn't trust us anymore. I also checked the Coaguchek order page at each of the same suppliers. No disclaimer for Coaguchek.

 

[bocco]

"Disclaimer:
I agree that I am a physician and or a licensed home healthcare facility. I have a medical license to purchase this product."

I looked at a few different suppliers websites where I have purchased InRatio strips in the past to see if they have strips available yet. The above disclaimer, or one similar, is now on every InRatio order page. It never was before. I guess InRatio doesn't trust us anymore. I also checked the Coaguchek order page at each of the same suppliers. No disclaimer for Coaguchek.

Donna,

Can you provide links to the suppliers that have the strips?

Thanks

Gary

 

[donnag131]

Gary,

http://www.inratiostrips.com/

http://www.medsupplier.com/alere-hemosense-inratio-2-pt-inr-test-strips-99008G2.aspx



Unfortunately both suppliers have disclaimers so I have no idea where to purchase strips legitimately anymore. Inratiostrips.com, where I've purchased for years, looks like they are serious about not selling for home use anymore. Either they weren't supposed to in the past and just got in trouble for it, or Alere is cracking down big time.

My PCP's office was not receptive to the idea of purchasing strips for me, so I have reluctantly signed on for Roche's home-testing. I had Alere's home-testing years ago before purchasing my own meter, and won't go back to them. All home-testing programs are an insurance rip-off, charging 2 to 3 times the amount of what I paid when buying them on my own, but I can't afford to buy a Coaguchek XS on my own right now, so I'm stuck.

Good luck to all self-sufficient home testers in the future!