device · product 1 of 1
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 number
- Z-2159-2012
- Initiated
- February 24, 2012
- Classification
- Class III
- Status
- Terminated
- Recalling firm
- Roche Molecular Systems, Inc.
- Quantity
- 264 kits to 13 EU countries; 2 kits to Canada and 33 kits to 11 countries in the Rest of the World
App-derived interpretation
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
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Inspect official wording and provenance
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
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.