Coaguchek xs test strips.recall

[Jimmyk]

Ok,
I recently started using ROCHE for a new machine and test strips . Today , I got a call to through all my test strips in the garbage , there has been a recall.
If you google it, ROCHE will have a list of all lot numbers.
Be safe everyone!

 

[Jimmyk]

Should have wrote throw all my test strips in the garbage .& ROCHE will have a list of all lot numbers affected by the recall.

 

[Warrick]

Thers an earlier post on this and dick started it I think,
it was a safety notice as the strips are still considered accurate up to INR 4.5, Unless you getting new ones for free I wouldnt throw them out as I was told there wont be any recalibrated strips available until later this month as the WHO sets the standard, which I think was a balls up on their part...

So is it a full recall now??
Do you have a link?

 

[Warrick]

The other post I was refering to
http://www.valvereplacement.org/foru...-strip-problem

And just found this
https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm624822.htm

so it is a full recall now

 

[pellicle]

Ok,
I recently started using ROCHE for a new machine and test strips . Today , I got a call to through all my test strips in the garbage , there has been a recall.

thanks Jimmy

I've just checked my last batch of 24 and the number on my bottle isn't on the list ... so all good there.

I assume that Roche will have a procedure for replaement or reimbursement (which is normal under recalls)

Best Wishes

 

[Bodhisattva]

Hi everyone, thanks so much for alerting us Jimmy.

I was noticing that the FDA recall notice is for lot numbers that have REF numbers that end in 160.

The earlier alert that dick brought to our attention is for lot numbers that have REF numbers that end in 019. That notice didn't say to stop using the REF 019 strips. It said the affected strips were ok for INR <= 4.5 but readings above this should be confirmed by a vein draw.

It is confusing because apparently the strips from both REF 160 and REF 019 were calibrated under that new standard that has been causing problems. But only the strips from REF 160 have been recalled in this Class I notice from the FDA. The recall notice doesn't mention the REF 019 strips at all.

Since the FDA notice is very serious Class I, you'd think they would have included the REF 019 strips if it was necessary, right?

So I don't get it. It looks like the REF 160 strips are more dangerous for some reason other than the calibration problem since they haven't also recalled REF 019 which were similarly calibrated.

Of course I have 48 of the recalled strips that I was just about to start using and have to discard now

And since I'm almost out I just got another 48 on ebay with REF 019 assuming they were ok since they weren't listed in the recall. But then I looked again at dick's notice and saw how it talked about REF 019.

So now I'm worried I made a mistake getting the REF 019 strips.

Anyway, I'm going to try calling Roche for answers even though I'm not an official patient of their system. I'll let you know if I get through and find out anything.

Again, thanks jimmy and dick for taking care of us.

 

[Warrick]

Same here my current strips listed in the first notice but not the recall
i’ll email Roche on Monday, they responded to me last time regarding the first notice

 

[Jimmyk]

According to the recorded message, it says that new strips will be mailed to everyone affected.
As for the box’s we purchased on eBay, I guess we’re out of luck there.

 

[Bodhisattva]

Hi everyone, here's an update:

I just spoke with US Roche technical support. She said strips with REF 160 are part of the US Roche market. Whereas strips with REF 019 are from the international/UK market. I double-checked the notice that was talking about REF 019 and you can see at the bottom that it is coming out of the UK.

The US Roche tech support said REF 160 US strips had originally been designated similarly to REF 019, that is, you could rely upon results <4.5 from these recalibrated strips, but for for INR results higher than 4.5, Roche said you should double-check the INR result with another method before making any treatment changes.

At first this was true for all the newly recalibrated strips whether REF 160/US or REF 019/UK.

US Roche then made this recent decision to completely recall REF 160 strips to remove any risk that the word wasn't getting out about rechecking INR >4.5 results before making any treatment changes. Although the tech person said it was all about protecting patients, which I'm sure is also true, I'm guessing US Roche is also looking at limiting their legal exposure with this recall.

I asked the US Roche tech if they had any other data changing their initial assessment that the recalibrated REF 160 strips were ok up to INR 4.5. The tech said no that wasn't it.

So it looks like the recalibrated strips, whether REF 160 or REF 019, are ok as long as you know you must double-check any result >4.5 by another method before implementing any treatment changes.

In any case, no doubt Roche is moving forward in all their regional markets to stop making recalibrated strips and go back to the earlier calibration standard on all strips going forward.

But for now US Roche is more risk adverse than the international/UK market. And while it may limit their liability, it is also very good for patients. So bravo US Roche for taking a loss on these strips and replacing them for free and all that.

That's not to say UK Roche won't also issue a total recall at some point as well.

But in the meanwhile, it looks like the underlying original assessment hasn't been withdrawn or changed by the recall, that is, that Roche recalibrated strips are ok up to 4.5.

So I'm thinking I may choose to use up my REF 160 strips for now since I know to double-check if appropriate.

And the ebay seller from whom I ordered the REF 019 strips is willing to cancel my order. So that's a relief!

Then my plan is to keep an eye out on ebay for strips with the proper REF and LOT numbers to start showing up. It may take a few months I bet. But once they do, I'll go ahead and buy a new box and discard my remaining REF 160 strips.

best wishes all

 

[Bodhisattva]

With regard to the original notice about REF 019 that dick alerted about here http://www.valvereplacement.org/foru...-strip-problem

In that thread, pellicle you said something like the 6% variance because of the recalibration means you might get slightly higher even if under 4.5, for example 2.7 instead of 2.6. I'm not sure how you did that math for that but I'll take your word for it.

That's why we have my range at 2.3-3 when it is officially 2-3. So if my weekly INR goes below 2.3, I report into my pcp immediately because I don't want to trend low. I'd rather be higher than lower. And so we'll discuss what to do based on my spreadsheet data. If my weekly is in this range, I just report in to my pcp every 4 weeks. At that time I give my pcp my current week's INR results. So her records are showing monthly results. But of course I'm maintaining my own spreadsheet of the weekly results along with any notes about any changes in my routines that week that may be relevent, be it eating more K or staying up really late or exercising less.

pellicle, your posts and comments were critical to my level of comfort about choosing a mechanical. I knew I didn't want to set myself up to do the op again. That I knew. That made the mech decision a no brainer even though I resisted having to make the choice between valve type at all of course. But I was sure I knew I would not set myself up for another operation. But the warfarin was a black box. Your post and comments really helped illuminate that box for me. It made me less anxious going forward, more prepared. Then once I was on the other side of the op, I did have to stay with the AC clinic while ramping up to therapeutic range. But I already knew about self-management and getting my own machine because of your writing. So I didn't have to figure it out, I just went out and got the machine and starting testing at home. I was able to show my clinician my spreadsheet and expressed my understanding based on your logical presentations. So she was willing to support me leaving the care of the clinic if my pcp was willing to manage me going forward. And my pcp was because, again, I had the spreadsheet and understanding. This saved me a bunch of money because each clinic visit was Expensive when you aren't on medicare. I think if you are on medicare, the visits are like $5 which is doable (although the costs of driving there doesn't go away) My operation was near the end of the year so I had maxed out my contribution by then and was getting everything for free. But once the new year started, I started paying for those clinic visits and it was cray cray how much each visit was billed, I think it was ~$90 to me. And wow when I can get strips for $4/test!!! I was paying for the clinician's time of course, her expertise, but even then my visits were always really short, in and out, like 15 minutes, so short. Plus since by then I was in range and stable, her expertise wasn't as needed as when I was ramping up. That's when the expertise of a clinic is the most useful I think. So anyway, dear pellicle, long story short, your efforts here helped me so much and so probably many others like me too. Thank you.

 

[pellicle]

Hi

With regard to the original notice about REF 019 that dick alerted about here ...
In that thread, pellicle you said something like the 6% variance because of the recalibration means you might get slightly higher even if under 4.5, for example 2.7 instead of 2.6. I'm not sure how you did that math for that but I'll take your word for it.

​​​​​

I did just a back of my hand calculation.

That's why we have my range at 2.3-3 when it is officially 2-3. So if my weekly INR goes below 2.3, I report into my pcp immediately because I don't want to trend low. I'd rather be higher than lower.

It's all a bit moot in my view (which I've covered before) and as long as you stick in the middle of your range your unlikely to come to harm.

​​​​​

But I already knew about self-management and getting my own machine because of your writing. So I didn't have to figure it out, I just went out and got the machine and starting testing at home. I was able to show my clinician my spreadsheet and expressed my understanding based on your logical presentations.

I'm glad

I was paying for the clinician's time of course, her expertise, but even then my visits were always really short, in and out, like 15 minutes, so short. Plus since by then I was in range and stable, her expertise wasn't as needed as when I was ramping up

Over time your own confidence will boost (and itsit's not like clinics are without error)

That's when the expertise of a clinic is the most useful I think. So anyway, dear pellicle, long story short, your efforts here helped me so much and so probably many others like me too. Thank you.

Feel free to email me and chat if you need to

 

[pellicle]

Bodhisattva I forgot to say "thank you" in my above post.

I thought I'd fish out a link to one of my arguments about INR being rubbery anyway

http://www.valvereplacement.org/for...ot-reading-inrs-correctly?p=849087#post849087

ultimately we all have much greater precision (certainly sufficent precision) to keep healthy

 

[Homeskillet]

Sooo, I just got an email tonight from my strip provider - and I talked to Roache - both of whom said to throw the strips away. The lot number for my strips was on the US Roache recall list.

However, tonight I tested on my Coag-Sense & tested 1.9 (I am running a little low right now). I then tested on my CoaguChek & tested 2.1. Two weeks ago I tested at 2.3 on my CoaguChek & was 2.2 with a lab draw (same day & same batch of strips).

So, I am not seeing where this batch is giving crazy results...and really don’t want to throw $200 down the drain. And, who knows when on earth this will be remedied!

I then got on the forum and - if I am understanding right - the recall for both US & UK Roache is only for a reading above 4.0 or above. Is that correct?

another great reason to keep this forum going!

 

[Warrick]

Homeskillet
yes thats close, so either batch of strips has been deemed safe, its only the variance of INRs over 4.5 percentage is too great, this becomes much more important at higher readings like this because it may influence a doctors decision to give vit k to lower a high inr when it may not be needed, I think realistically thats where the problems have arisen from what I can gather.
I dont know the technical aspects but basically the world health organisation (WHO) that set the calibration standards changed the specs that the strips must meet, roche manufactured their strips to this new standard but something in the specs is flawed, so roche didnt just make a bunch of dodgy strips off the cuff.

So the recommendation from roche has been INR readings above 4.5 need to be confirmed by a blood draw, and this is primerally to avoid vit k and bombing inrs when its not needed

 

[LondonAndy]

Here in the UK I occasionally buy accessories such as lancets directly from Roche, but get my test strips from my doctor on prescription. Because of my odd direct purchases they have written to me - here is the Roche UK info if of interest, which again confirms it would only be readings over 4.5 that would need to be rechecked. So keep calm and carry on with a stiff upper lip!

 

[Homeskillet]

Homeskillet
yes thats close, so either batch of strips has been deemed safe, its only the variance of INRs over 4.5 percentage is too great, this becomes much more important at higher readings like this because it may influence a doctors decision to give vit k to lower a high inr when it may not be needed, I think realistically thats where the problems have arisen from what I can gather.
I dont know the technical aspects but basically the world health organisation (WHO) that set the calibration standards changed the specs that the strips must meet, roche manufactured their strips to this new standard but something in the specs is flawed, so roche didnt just make a bunch of dodgy strips off the cuff.

So the recommendation from roche has been INR readings above 4.5 need to be confirmed by a blood draw, and this is primerally to avoid vit k and bombing inrs when its not needed

Got it. Thank you much! Hope you are well. Will just keep my batch then .

This thread was the first thing that hit my mind when I saw the email.

 

[dick0236]

I just received, via FedEx, new Coaguchek xs strips to replace recalled strips........problem solved.

 

[ForeverThankful]

I just received, via FedEx, new Coaguchek xs strips to replace recalled strips........problem solved.

Me too. They came FedEx and I had to sign for them.

 

[Jimmyk]

Good to know that their sending new ones out. On the message it said up to a month wait! That was fast?

 

[DachsieMom]

I received some yesterday! They arrived a few hours after I requested a scrip for a blood draw that now I don't need, thank goodness.