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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 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 CoumadinĀ® or warfarin.
Recall Number Z-1581-2013
Classification Class II
Code Info Model/Catalog/Part Number: 04837738001
Product Distributed Qty 204,205 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
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