Roche Molecular Systems, Inc. recalls cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in co…

Recall date

December 18, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0999-2015

FDA classification

Class III

Brand / firm

Roche Molecular Systems, Inc.

Sold / distributed

Foreign Distributed.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.