cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary

FDA device recall Z-0188-2013 · posted 2012-11-02 · Terminated

Recall details

Recalling firm

Roche Molecular Systems, Inc.

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

Action taken

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.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

OWD

Quantity affected

44 kits

Distribution

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

Date initiated

2012-07-31

Date posted

2012-11-02

Date terminated

2013-09-11

Location

S Branchburg, NJ