CLASS II Device recall · Reported 3 Jul 2013 · FDA Enforcement Report

CoaguChek XS Plus System The CoaguChek XS Plus system recalled

Roche Diagnostics Operations is recalling CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare, distributed nationwide in the US. The recall was initiated on 16 May 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Catalog/Part Number: 05021537001

Quantity recalled3343 meters

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1583-2013
FDA event ID: 65246
Recalling firm: Roche Diagnostics Operations, Indianapolis, IN
Classification: Class II
Status: Terminated
Recall initiated: 16 May 2013
FDA classified: 24 Jun 2013
Reported: 3 Jul 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

16 May 2013	Recall initiated by company
24 Jun 2013	Classified by FDA	+39 days
3 Jul 2013	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed.

Product as listed by the FDA

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.

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Is CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare recalled?

Yes. Roche Diagnostics Operations recalled CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare on 16 May 2013. The recall is Class II and its status is Terminated. Recall number Z-1583-2013.

Why was it recalled?

Which lots are affected?

Model/Catalog/Part Number: 05021537001

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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