Roche CoaguChek XS PST Meters Recalled for Potential Unit Misinterpretation
Roche is recalling CoaguChek XS PST meters because they may display blood-clotting results in the wrong units. Users should verify their meter is set to INR.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used for critical anticoagulation monitoring where incorrect unit display could lead to dangerous dosing errors, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 716,880 units of CoaguChek XS PST Meters, which are used by patients taking anticoagulation medications like Coumadin or warfarin to measure blood-clotting time. The recall was initiated because the meters may display results in %Quick or Seconds instead of the required INR units, leading to possible misinterpretation of the data.
The affected products were distributed nationwide in the United States. The recall covers all serial numbers for the specific catalog number 04837738001.
Consumers using these meters should check their device settings to ensure it is configured to display INR results. The recall firm is providing instructions to users to help them verify the correct display unit.
The recalled product
- 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
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 716,880
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Roche Diagnostics Operations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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