Roche Recalls Cobas KRAS Mutation Test Kits Due to Stability Concerns
Roche Molecular Systems is recalling specific lots of the Cobas KRAS Mutation Test because stability testing showed the kits trended toward the upper specification limit for codon 61 peak height ratio.
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 FDA classified this recall as Class III, which by definition indicates that use of or exposure to the product is not likely to cause adverse health consequences. The issue is a stability trend within specifications rather than a confirmed failure or reported injury.
Plain-English summary
Roche Molecular Systems, Inc. is recalling the Cobas KRAS Mutation Test for In Vitro Diagnostic Use. This recall involves Lot P06778, which was distributed worldwide to 13 EU countries, Canada, and 11 other countries. The product is a real-time PCR test used to identify mutations in the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer.
The recall was initiated after real-time stability testing identified that the kit was just within specifications for the codon 61 peak height ratio. The testing showed that the kit trended towards the upper specification limit at the 6-month time point, although it did pass the 6-month stability testing. The kit is labeled for a 9-month shelf life stability.
The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Healthcare facilities and laboratories should stop using the affected kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutation Test, for use with the Cobas 4800 System, is a real-time PCR test intended for the identification of mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from form
- Manufacturer
- Roche Molecular Systems, Inc.
- Hazard
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)
- 05852170190
- Lot P06778
Distribution
Distribution scope not specified by the agency.
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