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U.S. Department of Health and Human Services

Enforcement Report - Week of July 3, 2013

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Product Detail

Product Description CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (non anticoagulated venous whole blood).
Recall Number Z-1582-2013
Classification Class II
Code Info Model/Catalog/Part Number: 05530199160
Product Distributed Qty 537 meters total
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.

Event Detail

Event Id 65246
Product Type Devices
Status Ongoing
Recalling Firm Roche Diagnostics Operations, Inc.
City Indianapolis
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution