Class 3 Device Recall cobas KRAS Mutation Test

• Date Initiated by Firm: February 24, 2012
• Date Posted: August 08, 2012
• Recall Status: Terminated on July 16, 2013
• Recall Number: Z-2159-2012
• Recall Event ID: 62500
• Product Classification: real time Nucleic acid amplification system - Product Code OOI
• Product: 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).
• Code Information: 05852170190; Lot P06778
• Recalling Firm/ Manufacturer: Roche Molecular Systems, Inc.; 1080 Us Highway 202 S; Branchburg NJ 08876-3733
• For Additional Information Contact: Mr. Vincent C. Stagnitto; 908-253-7569
• Manufacturer 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
• FDA Determined 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 in Commerce: 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 and Turkey.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.