FDA Device recall Z-0999-2015
cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test
- FDA Device
- Class III
- terminated
- Published 2015-01-28
On 2015-01-28 the FDA classified a Class III recall of cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test by Roche Molecular Systems, citing cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0999-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-12-18 |
| Published | 2015-01-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Roche Molecular Systems |
| Distribution | n/a |
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.
Identifiers
| code_info | Lots T10786 T13091, T15435, T15475, T14777, and W00389 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0999-2015%22
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