Roche Diagnostics Operations, Inc.: Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results

Agency Publication Date: January 7, 2021

Affected Products

Product: CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975001 Units could consist of any of the following strip configurations: 6 count, 24 count, 2x 24 count (i.e. 48 strips)* *CoaguChek XS 3x48 promo LTC HH Catalog: 06298176001 CoaguChek XS 6x24 promo LTC HH Catalog:08468699001 CoaguChek XS 4x48 promo Catalog: 08468745001 CoaguChek XS 6x48 promo

All serial numbers

Product: CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001

All serial numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86951

Status: Resolved

Manufacturer: Roche Diagnostics Operations, Inc.

Manufactured In: United States

Units Affected: 2 products (212,093 units; 716,880 units)

Agency Last Updated: January 21, 2021

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Sources: FDA iRES · Raw API Response

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Affected Products

All serial numbers

Product: CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001

All serial numbers