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U.S. Department of Health and Human Services

Class 3 Device Recall Roche cobas

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 Class 3 Recall
Roche cobas
see related information
Date Posted November 02, 2012
Recall Status1 Terminated on September 11, 2013
Recall Number Z-0188-2013
Recall Event ID 63310
Premarket Approval
PMA Number
P110020
Product Classification Somatic Gene Mutation Detection System - Product Code OWD
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).
Code Information Material number 05985595190; Lot number R03607
Recalling Firm/
Manufacturer
Roche Molecular Systems, Inc.
1080 Us Highway 202 S
Branchburg, New Jersey 08876-3733
For Additional Information Contact Mr. Vincent C. Stagnitto
908-253-7200
Manufacturer 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
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = OWD and Applicant = ROCHE MOLECULAR SYSTEMS, INC.
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