Z-0188-2013Class III

cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc

Name: Z-0188-2013 cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc
Creator: Roche Molecular Systems, Inc.
Published: 2012-07-31
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2012-07-31 / Terminated / root cause: packaging

FDA source

Roche Molecular Systems, Inc. began a recall of cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4800 BRAF V600... on 2012-07-31. FDA classified it as Class III and gives the reason as "It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packaged into cobas 4800 BRAF V600 Mutation Test CE-IVD kit lot R03607 and released for distribution. Two control batches...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0188-2013
Classification: Class III
Status: Terminated
Initiated: 2012-07-31
Posted: 2012-11-02
Terminated: 2013-09-11
Recalling firm: Roche Molecular Systems Inc
Product: cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. It is intended to be used as an aid in selecting melanoma patients whose tumors carry BRAF V600 mutations for treatment with Zelboraf (vemurafenib).
Product code: OWD Somatic Gene Mutation Detection System
Reason for recall: It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packaged into cobas 4800 BRAF V600 Mutation Test CE-IVD kit lot R03607 and released for distribution. Two control batches manufactured during two process validation studies are involved: PV7711: BRAF Mutant (MUT) Control PV0853: BRAF Wild Type (WT) Control
Root cause tag: packaging
FDA root cause: Mixed-up of materials/components
Action: Roche sent a Safety Board Notice - Product Bulletin 2012-013 on 31-Jul-2012 to affected customers. The notice identifed the affected product, description of situation and actios to be taken. Customers were instructed to discontinue use, quarantine and discard any remaining kits of the affected product in inventory. Customers were advised to contact their affiliate sales office for replacement. The notice states a new cobas 4800 BRAF V600 Mutation Test lot (R07749) is anticipated to be available on 03-Aug-2012. For questions call +01.908.253.7569.
Quantity in commerce: 44 kits
Distribution: Worldwide Distribution - Australia, Austria, Belgium, China, Hungary, Turkey and United Kingdom.
Product codes and lots: Material number 05985595190; Lot number R03607

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0188-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0188-2013	Class III	Terminated	Voluntary: Firm initiated	2012-11-07	2012-11-01

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