Roche Recalls cobas 4800 BRAF V600 Mutation Test Kits
Roche Molecular Systems is recalling 44 kits of the cobas 4800 BRAF V600 Mutation Test because internal-use controls were incorrectly packaged into the product.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue involves packaging error of internal controls rather than a direct safety hazard to patients.
Plain-English summary
Roche Molecular Systems, Inc. is recalling 44 kits of the cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use. The affected product is identified by Material number 05985595190 and Lot number R03607. The test is used to detect BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue to aid in selecting patients for treatment with Zelboraf (vemurafenib).
The recall was initiated because BRAF controls designated as "Internal Use Only" were incorrectly packaged into the CE-IVD kits and released for distribution. Two specific control batches manufactured during process validation studies were involved: PV7711 (BRAF Mutant Control) and PV0853 (BRAF Wild Type Control).
The affected kits were distributed worldwide, including in Australia, Austria, Belgium, China, Hungary, Turkey, and the United Kingdom. Healthcare facilities and laboratories should stop using the affected kits and contact Roche for further instructions.
The recalled product
- 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 me
- Manufacturer
- Roche Molecular Systems, Inc.
- Affected units
- 44
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Material number 05985595190
- Lot number R03607
Distribution
Distribution scope not specified by the agency.
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