Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutation Test, for use with th

FDA device recall Z-2159-2012 · posted 2012-08-08 · Terminated

Recall details

Recalling firm

Roche Molecular Systems, Inc.

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

OOI

Quantity affected

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,

Date initiated

2012-02-24

Date posted

2012-08-08

Date terminated

2013-07-16

Location

S Branchburg, NJ