Roche Molecular Systems, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0999-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: December 18, 2014

Date Posted: January 28, 2015

Recall Number: Z-0999-2015

Event ID: 70058

Reason for Recall:

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

Status: Terminated

Product Quantity: 660 pieces

Code Information:

Lots T10786 T13091, T15435, T15475, T14777, and W00389

Distribution Pattern:

Foreign Distributed.

Voluntary or Mandated:

Voluntary: Firm initiated