Z-1346-2013Class II

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

Name: Z-1346-2013 cobas 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from...
Creator: Roche Molecular Systems, Inc.
Published: 2013-04-01
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2013-04-01 / Terminated / root cause: software

FDA source

Roche Molecular Systems, Inc. began a recall of cobas 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes on 2013-04-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1346-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-01
Posted: 2013-05-21
Terminated: 2014-08-07
Recalling firm: Roche Molecular Systems Inc
Product: cobas 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
Product code: OOI Real Time Nucleic Acid Amplification System
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
Root cause tag: software
FDA root cause: 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.
Product codes and lots: Material Number 05200881001 - all lot/serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1346-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1346-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-21

Product code OOI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)