Recall Z-0188-2013— Roche Molecular Systems, Inc.

Class III FDA medical device recall by Roche Molecular Systems, Inc., initiated 2012-07-31, terminated 2013-09-11. FDA's recall record names no specific 510(k) clearance for this event. 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).. Reason: 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.

Recalling firm

Roche Molecular Systems, Inc.

Classification

Class III

Status

Terminated

Initiated

2012-07-31

Terminated

2013-09-11

Firm location

Branchburg, NJ, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.