Z-0999-2015Class III

cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of...

Name: Z-0999-2015 cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of...
Creator: Roche Molecular Systems, Inc.
Published: 2014-12-18
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2014-12-18 / Terminated / root cause: design

FDA source

Roche Molecular Systems, Inc. began a recall of cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in... on 2014-12-18. FDA classified it as Class III and gives the reason as "cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0999-2015
Classification: Class III
Status: Terminated
Initiated: 2014-12-18
Posted: 2015-06-26
Terminated: 2017-02-08
Recalling firm: Roche Molecular Systems Inc
Product: cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.
Product code: OWD Somatic Gene Mutation Detection System
Reason for recall: cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.
Root cause tag: design
FDA root cause: Device Design
Action: RMS issued an Urgent Field Safety Notice on 12/18/2014. A Quality Notification was provided to all users of the of cobas KRAS Mutation Kit CE-IVD, lots T13091, T15435, T15475, T14777, and W00389, informing them of the issue and instructing them to discontinue use and discard any remaining inventory immediately.
Quantity in commerce: 660 pieces
Distribution: Foreign Distributed.
Product codes and lots: Lots T10786 T13091, T15435, T15475, T14777, and W00389

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0999-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0999-2015	Class III	Terminated	Voluntary: Firm initiated	2015-01-28	2015-01-20

Product code OWD

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)