Z-2159-2012Class III

Cobas KRAS Mutation Test for In Vitro Diagnostic Use

Name: Z-2159-2012 Cobas KRAS Mutation Test for In Vitro Diagnostic Use
Creator: Roche Molecular Systems, Inc.
Published: 2012-02-24
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2012-02-24 / Terminated / root cause: manufacturing process

FDA source

Roche Molecular Systems, Inc. began a recall of 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... on 2012-02-24. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2159-2012
Classification: Class III
Status: Terminated
Initiated: 2012-02-24
Posted: 2012-08-08
Terminated: 2013-07-16
Recalling firm: Roche Molecular Systems Inc
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).
Product code: OOI Real Time Nucleic Acid Amplification System
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
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: 05852170190; Lot P06778

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2159-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2159-2012	Class III	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-08

Product code OOI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)