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.