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U.S. Department of Health and Human Services

Enforcement Report - Week of May 29, 2013

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Event Detail

Event ID 64930
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 2013-04-01
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
cobas® 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes. Material Number 05200881001 - all lot/serial numbers. Class II In rare instances, channel shifted results have been generated with cobas® 4800 assays run on v1.1.1 of the cobas® 4800 system. Raw data review indicates that, in these cases, all signals are shifted by one channel: channel 1 results report as channel 2, channel 2 results report as channel 3, channel 3 results report as channel 4, and channel 4 results report as channel 1. In the reported cases, the results of the runs were either invalid or the preponderance of individual patient specimen showed to be invalid. 425 instruments Z-1346-2013