The Recall Desk
HighFDA (Devices)·Z-1581-2013·Announced 2013-07-03

Roche Recalls CoaguChek XS Meters Due to Potential INR Test Errors

Roche is recalling CoaguChek XS meters because they may display an error message instead of a value, potentially leading to undetected elevated INR results.

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 medication management where a failure could lead to undetected health risks, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling 204,205 CoaguChek XS System meters, including the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro models. The recall is due to a potential for undetected elevated INR test results. In rare cases, the device may display an ERROR 6 message instead of a numerical value.

The CoaguChek XS System is used to measure blood-clotting time for individuals taking anticoagulation medications such as Coumadin or warfarin. An undetected elevated INR result could impact the management of these medications. The affected meters were distributed nationwide.

Consumers should stop using the recalled meters and contact Roche Diagnostics Operations, Inc. for further instructions or a replacement.

The recalled product

Product
CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin¿ or warfarin.
Manufacturer
Roche Diagnostics Operations, Inc.
Category
Medical Device — Point-of-Care Testing
Hazard

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: 04837738001

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.

See all 4 products in this recall →

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Same manufacturer · Roche Diagnostics Operations, Inc.

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