Reported Nov 14, 2018 · Terminated
CoaguChek¿ XS System Prothrombin time test
Roche Diagnostics Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Corporation · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
CoaguChek¿ XS System Prothrombin time test
3 of 3 products
| Model / number | Product as published |
|---|---|
04625315160 | CoaguChek XS PT Test 2X24 Strips |
04625374160 | CoaguChek XS PT Test 6 Strips |
07797826160 | CoaguChek XS PT Test 24 Tests |
- Amount recalled
- 1,163,952 boxes
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Abnormally high INR test results with the affected CoaguChek test strips
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Roche Diagnostics Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.