Recall Z-2159-2012 ยท OOI Real Time Nucleic Acid Amplification System
Roche Molecular Systems, Inc.
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).
| Date | Aug 8, 2012 (initiated Feb 24, 2012) |
| Status | Terminated |
| 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 |
| Root cause | Nonconforming Material/Component |
| Action | Roche issued a Safety Board Notice (Prooduct Support Notice 2012-01) and Product Bulletin 2012/03 dated February 24, 2012 to all affected customers. The notice idenfied the affected product, description of situation and actions to be taken. Customers were instructed to discontinue use of lot P06778 by March 4, 2012 and to quarantine and discard any remaining kits from lot P06778. The notice stated that a new lot will be made available as a replacement. |
| Quantity | 264 kits to 13 EU countries; 2 kits to Canada and 33 kits to 11 countries in the Rest of the World |
| Distribution | 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 an |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.