Roche Molecular Systems, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0188-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class III

Date Initiated: July 31, 2012

Date Posted: November 7, 2012

Recall Number: Z-0188-2013

Event ID: 63310

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

Status: Terminated

Product Quantity: 44 kits

Code Information:

Material number 05985595190; Lot number R03607

Distribution Pattern:

Worldwide Distribution - Australia, Austria, Belgium, China, Hungary, Turkey and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated