medical Class II Updated 2021-01-13

Roche Diagnostics Operations, Inc. recalls CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures

Recalled 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

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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