Coaguchek INR testing strips recall
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Hello everyone,
I just received notice that Roche recalled INR testing strips on 10/31/18.
I just wanted to give a "head's up" to everyone who uses these strips. Apparently, an announcement was sent out, which I didn't receive, but another person gave me and of course, my current lot was recalled and we are forced to stop testing. Only venipunctures are allowed until I get the unaffected lot through Fisher.
Thanks,
Julie Brim, CLS MS
POC supervisor
The Vancouver Clinic
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Do you have the product insert?
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Not insert but the announcement?
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I called Roche today and they said a form from Stericycle should be coming out next week so you can fill out which lots and how many you have. Then they will send out replacements.
Here's the announcement.
Thank you,
Julie
Thank you
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Google Roche Recall 2018 for more information. It is a Class 1 FDA recall. It sounds like the recall was initiated on September 13,2018.
I just love it when this stuff comes out on a Friday afternoon! Thank God for the ListServ or we wouldn't have found out about it for weeks!
Initially it was just that the coagucheck did not match labs when results were above 3.5 of the lab had not updated to the new international whatever.
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What is really annoying is Roche couldn't have proactively provided customers with corrected strips to keep from impacting patients during the replacement.
I faxed and emailed the product replacement form, but haven't heard anything back. I assume it will take some time, but has anyone else heard anything about how long it is taking for them to send out replacement strips?
We haven't gotten the replacement strips.
I was able to order strips through Medline.
We got some next day through our Fisher rep. Suggest contacting your supplier.
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