Roche Recalls cobas 4800 KRAS Mutation Test Kits for Invalid Results
Roche Molecular Systems is recalling cobas 4800 KRAS Mutation Test kits because they are generating invalid results for the Mutant Control and/or KRAS Calibrator.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a remote possibility of adverse health consequences. The issue involves invalid test results rather than a direct physical hazard like injury or death, fitting the criteria for a moderate severity score.
Plain-English summary
Roche Molecular Systems, Inc. is recalling 660 pieces of the cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test. The affected lots are T10786, T13091, T15435, T15475, T14777, and W00389. The product was distributed in foreign markets.
The recall was initiated because the cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator. This test is intended for the identification of mutations in codons 12, 13, and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.
The U.S. Food and Drug Administration has classified this recall as Class III. Users of the affected kits should stop using them and contact the manufacturer for further instructions.
The recalled product
- Product
- cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.
- Manufacturer
- Roche Molecular Systems, Inc.
- Hazard
- Affected units
- 660
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 (5)
- Lots T10786 T13091
- T15435
- T15475
- T14777
- and W00389
Distribution
Distribution scope not specified by the agency.
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