FDAFDA · Food and drugs·Recall number Z-0188-2013
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).
Published November 7, 2012 · Recall initiated: July 31, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Roche Molecular Systems, Inc.
- Distributor
- Worldwide Distribution - Australia, Austria, Belgium, China, Hungary, Turkey and United Kingdom.
- Lot
- Material number 05985595190; Lot number R03607
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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