Reported Jan 13, 2021 · Terminated
CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time…
Roche Diagnostics Operations, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 Operations, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy
- Catalog04837975001 Units could consist of any
- of the following strip configurations
6 count24 count2x 24 count (i.e. 48 strips)* *CoaguChek
- XS 3x48 promo LTC HH Catalog06298176001
- CoaguChek XS 6x24 promo LTC HH Catalog08468699001
- CoaguChek XS 4x48 promo Catalog08468745001
- CoaguChek XS 6x48 promo Catalog08468753001
- Lot codes and dates
- All serial numbers
- Amount recalled
- 212,093 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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