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Terminated

cobas 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.

FDA Recall Z-1346-2013 · Posted 2013-05-21

Recalling FirmRoche Molecular Systems, Inc.
Recall StatusTerminated
Product CodeOOI
Date Initiated2013-04-01
Date Terminated2014-08-07
Product Quantity425 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

Firm 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.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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