Roche Molecular Systems, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2159-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class III

Date Initiated: February 24, 2012

Date Posted: August 15, 2012

Recall Number: Z-2159-2012

Event ID: 62500

Reason for Recall:

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

Status: Terminated

Product Quantity: 264 kits to 13 EU countries; 2 kits to Canada and 33 kits to 11 countries in the Rest of the World

Code Information:

05852170190; Lot P06778

Distribution Pattern:

Worldwide Distribution - including the countries of Austria, Belgium, Czech Republic, Denmark, Germany, Italy, Luxemburg, Netherlands, Poland, Slovakia, Slovenia, Spain, United Kingdom, Canada, Chile, Greenland, Hong Kong, Israel, Malaysia, New Zealand, Philippines, S. Africa, Switzerland, Taiwan and Turkey.

Voluntary or Mandated:

Voluntary: Firm initiated