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CoaguChek XS Plus System recallZ-1583-2013 · Roche Diagnostics Operations, Inc. · initiated May 16, 2013

Class II Terminated All recalls posted in June 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Roche Diagnostics Operations, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software design

What the company is doing

Rochet sent an Urgent Medical Device Correction letter dated May 16, 2013, via UPS Ground to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were issued the following instructions: If you are using Warfarin therapy in combination with antibiotics and/or chemotherapy drugs, which could potentially lead to an extremely high test result (> 10 INR), you may in rare cases receive repeated ERROR 6 messages instead of a test result. If the ERROR 6 message is displayed repeatedly on your CoaguChek XS meter, immediately contact your treating physician. The CoaguChek XS PT Test Strip package insert; the online version of the CoaguChek XS PST system users manual; and the CoaguChek XS systems are being updated to provide additional ERROR 6 message information and actions. Updated versions will be available on the www.poc.roche.com website by the end of June 2013. Health Care Professionals are instructed to use an alternative method to determine INR results if an ERROR 6 message is displayed repeatedly on the CoaguChek XS, CoaguChek XS Plus, or CoaguChek XS Pro meters for the same patient. Self testing patients are instructed to contact their Health Care provider immendiately if the ERROR 6 message is displayed repeatedly on the CoaguChek XS. Please contact your Roche Account Manager or Roche Diagnostics Point of Care Technical Service, 24 hours a day, seven days a week at 1-800-428-4674 if you have questions about the information contained in this UMDC. For questions regarding this recall call 317-521-3711.

Recall details

Recall number
Z-1583-2013
Recall class
Class II
Status
Terminated
Initiated by the company
May 16, 2013
Posted by the FDA
Jun 24, 2013
Recalling firm
Roche Diagnostics Operations, Inc.
Quantity
3343 meters
Product code
GJS
FDA submissions
K071041
Distribution
Nationwide Distribution

Product description

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.

Code information (models, lots, serial numbers)

Model/Catalog/Part Number: 05021537001

Other devices under the same FDA submission

1 device cleared under K071041 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 65246).

Sources and updates

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