cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test recall
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…
Why was cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test recalled?
cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots T10786 T13091, T15435, T15475, T14777, and W00389
- 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…
- Recalling firm
- Roche Molecular Systems, Inc.
- Quantity
- 660 pieces
- Distribution
- Foreign Distributed.
- Recall date
- January 28, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)