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U.S. Department of Health and Human Services

Enforcement Report - Week of May 29, 2013

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Product Detail

Product Description cobas® 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
Recall Number Z-1346-2013
Classification Class II
Code Info Material Number 05200881001 - all lot/serial numbers.
Product Distributed Qty 425 instruments
Reason For Recall 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.

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 Letter
Distribution Pattern Nationwide Distribution.