Reported Jan 28, 2015 · Terminated
cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in…
Roche Molecular Systems, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Molecular Systems, Inc. · 1080 Us Highway 202 S · Branchburg, NJ · 08876-3733
Is this the product you have?
- 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.
- Lot codes and dates
Lots T10786 T13091T15435T15475T14777and W00389
- Amount recalled
- 660 pieces
Why it was recalled
cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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