cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identifi...
FDA Recall #Z-0999-2015 — Class III — December 18, 2014
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.
Recalling Firm
Roche Molecular Systems, Inc. — Branchburg, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
660 pieces
Distribution
Foreign Distributed.
Code Information
Lots T10786 T13091, T15435, T15475, T14777, and W00389
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated