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U.S. Department of Health and Human Services

Class 2 Device Recall cobas 4800

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  Class 2 Device Recall cobas 4800 see related information
Date Initiated by Firm April 01, 2013
Date Posted May 21, 2013
Recall Status1 Terminated 3 on August 07, 2014
Recall Number Z-1346-2013
Recall Event ID 64930
Product Classification real time Nucleic acid amplification system - Product Code OOI
Product cobas¿ 4800 system z480 instrument.

Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
Code Information Material Number 05200881001 - all lot/serial numbers.
Recalling Firm/
Manufacturer		 Roche Molecular Systems, Inc.
1080 Us Highway 202 S
Branchburg NJ 08876-3733
Manufacturer 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
FDA Determined
Cause 2		 Software design
Action Roche sent an "Urgent Medical Device Correction" (UMDC) notification with response form dated April 1, 2013, to all affected customers via UPS Ground on April 1, 2013. The letter identified the product, the problem, and the action to be taken by the customer. A contact number (Roche Diagnostic Technical Support) is provided for technical support 24 hours a day, seven days a week at phone number: 1-888-912-7090.
Quantity in Commerce 425 instruments
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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