Device 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.
Z-0999-2015
Product summary
- Event
- Event 70058
- Status
- Terminated
- Classification
- Class III
- Quantity
- 660 pieces
- Official record key
device-enforcement:Z-0999-2015
Official wording
Reason: cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.
Code information: Lots T10786 T13091, T15435, T15475, T14777, and W00389
Distribution pattern: Foreign Distributed.
Derived failure modes
-
Unknown
cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.