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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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Event Detail

Event ID 62500
Product Type Devices
Status Ongoing
Recalling Firm Roche Molecular Systems, Inc.
City Branchburg
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-02-24
Initial Firm Notification of
Consignee or Public
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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). 05852170190; Lot P06778 Class III 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 data shows that the commercial kits are degrading at an accelerated rate when compared to pilot lots. The degradation will lead to an increased rate of invalid results but will not cause incorrect calls. 264 kits to 13 EU countries; 2 kits to Canada and 33 kits to 11 countries in the Rest of the World Z-2159-2012