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).

Recall Insight

This FDA Devices action (record #Z-2159-2012) was formally reported on August 15, 2012, with the manufacturer initiating the action on February 24, 2012. It is classified under Low severity (Class III), with a current status of Terminated. Roche Molecular Systems, Inc. is listed as the recalling firm, operating out of Branchburg, NJ. Federal records indicate 264 kits to 13 EU countries; 2 kits to Canada and 33 kits to 11 countries in the Rest of the World units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: 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 ha… Distribution data in the federal record shows the product reached: 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 Ko…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 14 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.