medical Class II Updated 2021-01-13

Roche Diagnostics Operations, Inc. recalls CoaguChek XS Prof (Professional) Meters- IVD professional he

Recalled 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 Catalog: 08468753001

Hazard / Issue

Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All serial numbers
View official government recall

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