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U.S. Department of Health and Human Services

Enforcement Report - Week of January 2, 2013

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Event Detail

Event ID 63814
Product Type Devices
Status Ongoing
Recalling Firm Roche Molecular Systems, Inc.
City Branchburg
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-11
Initial Firm Notification of
Consignee or Public
Distribution Pattern Distributed in the states of GA, CA, NC, and MN.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland CAP 394436 to 394663 Class II Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging feature disabled during quality control release resulting in samples that may not be flagged as having clots. 7 units Z-0614-2013