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.
- Company
- Roche Molecular Systems, Inc.
- Recall Initiated
- December 18, 2014
- Posted
- June 26, 2015
- Terminated
- February 8, 2017
- Recall Number
- Z-0999-2015
- Quantity
- 660 pieces
- Firm Location
- Branchburg, NJ
Reason for Recall
cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.
Distribution
Foreign Distributed.
Lot / Code Info
Lots T10786 T13091, T15435, T15475, T14777, and W00389
Root Cause
Device Design
Action Taken
RMS issued an Urgent Field Safety Notice on 12/18/2014. A Quality Notification was provided to all users of the of cobas KRAS Mutation Kit CE-IVD, lots T13091, T15435, T15475, T14777, and W00389, informing them of the issue and instructing them to discontinue use and discard any remaining inventory immediately.
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