Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time Recalled by Roche Diagnostics Operations, Inc. Due to Possible Misinterpretation of Displayed Measuring Units from INR...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Roche Diagnostics Operations, Inc. directly.
Affected Products
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
Quantity: 716,880 units
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Roche Diagnostics Operations, Inc.
Roche Diagnostics Operations, Inc. has 127 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report