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Terminated

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.

FDA Recall Z-0999-2015 · Posted 2015-06-26

Recalling FirmRoche Molecular Systems, Inc.
Recall StatusTerminated
Product CodeOWD
Date Initiated2014-12-18
Date Terminated2017-02-08
Product Quantity660 pieces

Reason for Recall

cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.

Firm Action

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

Distribution Pattern

Foreign Distributed.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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