Roche Recalls CoaguChek XS Plus Systems Due to Potential Test Errors
Roche is recalling CoaguChek XS Plus systems because they may display an error message instead of a value, potentially leading to undetected elevated INR results.
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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed incidents.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 3,343 CoaguChek XS Plus systems. These devices are used by professional healthcare providers for quantitative prothrombin time testing to monitor warfarin therapy. The recall covers units with model/catalog/part number 05021537001 that were distributed nationwide.
The recall was initiated because Roche confirmed the potential for an undetected elevated INR test result. In rare cases, the device may display an ERROR 6 message instead of a numerical value. This issue affects the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters.
Healthcare providers should stop using the affected devices and contact Roche for instructions on how to proceed.
The recalled product
- Product
- CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.
- Manufacturer
- Roche Diagnostics Operations, Inc.
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)
- Model/Catalog/Part Number: 05021537001
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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