cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in cod
FDA device recall Z-0999-2015 · posted 2015-06-26 · Terminated
Recall details
- Recalling firm
- Roche Molecular Systems, Inc.
- Reason for recall
- cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OWD
- Quantity affected
- 660 pieces
- Distribution
- Foreign Distributed.
- Date initiated
- 2014-12-18
- Date posted
- 2015-06-26
- Date terminated
- 2017-02-08
- Location
- S Branchburg, NJ
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