Recall Z-0999-2015— Roche Molecular Systems, Inc.
Class III · Terminated
Class III FDA medical device recall by Roche Molecular Systems, Inc., initiated 2014-12-18, terminated 2017-02-08. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator..
- Recalling firm
- Roche Molecular Systems, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2014-12-18
- Terminated
- 2017-02-08
- Firm location
- Branchburg, NJ, United States
Product description
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.
Reason for recall
cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.
Data sourced from openFDA. This site is unofficial and independent of the FDA.