Roche CoaguChek XS Prof Meters Recalled for Potential Unit Misinterpretation
Roche is recalling CoaguChek XS Prof meters because they may display results in incorrect units, potentially leading to misinterpretation of warfarin monitoring data.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 monitoring warfarin therapy, where incorrect unit display could lead to significant clinical errors. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling CoaguChek XS Prof (Professional) Meters used by healthcare providers for quantitative prothrombin time testing. The recall involves 212,093 units distributed nationwide in the United States. The meters are used to monitor warfarin therapy, a critical aspect of patient care for those on anticoagulant medication.
The recall is due to a potential misinterpretation of displayed measuring units. Specifically, the meters may display results in %Quick or Seconds instead of the intended International Normalized Ratio (INR). This discrepancy could lead to incorrect interpretation of test results by healthcare providers.
Healthcare providers using these devices should check their meters to ensure they are displaying INR results. Instructions have been provided to users to verify the correct unit display. Patients should consult their healthcare providers regarding their warfarin monitoring and any potential impact on their treatment.
The recalled product
- Product
- CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975001 Units could consist of any of the following strip configurations: 6 count, 24 count, 2x 24…
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 212,093
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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