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FDADecember 2, 2020device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

roche diagnostics operationsrocheroche diagnostics

UPCs

04837738001

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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