Recall Z-2159-2012— Roche Molecular Systems, Inc.

Class III FDA medical device recall by Roche Molecular Systems, Inc., initiated 2012-02-24, terminated 2013-07-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutation Test, for use with the Cobas 4800 System, is a real-time PCR test 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 cancer (CRC).. Reason: During the real-time stability testing for the cobas KRAS Mutation Test on the commercial lot PO6778, it was identified that the kit was just within specifications for the codon 61 peak height ratio, and that the kit has trended towards the upper specification limit at the 6 month time point but did passed the 6 month stability testing. The kit is labeled for 9 months shelf life stability. The d.

Recalling firm

Roche Molecular Systems, Inc.

Classification

Class III

Status

Terminated

Initiated

2012-02-24

Terminated

2013-07-16

Firm location

Branchburg, NJ, United States

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