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-embed
Check against the official notice below — it lists the full affected range.
Roche Molecular Systems, Inc. is recalling commercial lot P06778 of the Cobas KRAS Mutation Test, which is used with the Cobas 4800 System for real-time PCR testing. During stability testing, the kit was found to be just within specifications for the codon 61 peak height ratio, though it had trended toward the upper specification limit at the 6-month mark. Although the kit passed its 6-month stability testing, it is labeled with a 9-month shelf life.
The affected lot, identified as 05852170190, was distributed worldwide to 13 European Union countries, Canada, and 11 additional countries across the rest of the world, affecting a total of 264 kits in the EU, 2 kits in Canada, and 33 kits in other regions. The source document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 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 and Turkey. Quantity: 264 kits to 13 EU countries; 2 kits to Canada and 33 kits to 11 countries in the Rest of the World Lot/code info: 05852170190; Lot P06778
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.