—#118363

Product

CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.

FDA product code: GJS — Test, Time, Prothrombin
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K060978
Affected lot / code info: Model/Catalog/Part Number: 04837975001 and 04625412160

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2013-05-16
Posted by FDA: 2013-06-24
Terminated: 2014-04-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118363. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.