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CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who a...

FDA Recall #Z-0804-2021 — Class II — December 2, 2020

Recall #Z-0804-2021 Date: December 2, 2020 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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

Recalling Firm

Roche Diagnostics Operations, Inc. — Indianapolis, IN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

716,880 units

Distribution

US Nationwide

Code Information

All serial numbers

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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