cobas 4800 BRAF V600 Mutation Test for In Vitro recall
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…
Why was cobas 4800 BRAF V600 Mutation Test for In Vitro recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Material number 05985595190; Lot number R03607
- 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…
- Recalling firm
- Roche Molecular Systems, Inc.
- Quantity
- 44 kits
- Distribution
- Worldwide Distribution - Australia, Austria, Belgium, China, Hungary, Turkey and United Kingdom.
- Recall date
- November 7, 2012
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)