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
Reported: January 13, 2021 Initiated: December 2, 2020 #Z-0804-2021
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
Details
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Units Affected
- 716,880 units
- Distribution
- US Nationwide
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 716,880 units.
Why was this product recalled? ▼
Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 13, 2021. Severity: Moderate. Recall number: Z-0804-2021.
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