CLASS III Device recall · Reported 15 Aug 2012 · FDA Enforcement Report
Cobas KRAS Mutation Test for In Vitro Diagnostic Use recalled
Roche Molecular Systems is recalling Cobas KRAS Mutation Test for In Vitro Diagnostic Use. The recall was initiated on 24 Feb 2012 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2159-2012
- FDA event ID
- 62500
- Recalling firm
- Roche Molecular Systems, Branchburg, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 Feb 2012
- FDA classified
- 8 Aug 2012
- Reported
- 15 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 24 Feb 2012 | Recall initiated by company | |
| 8 Aug 2012 | Classified by FDA | +166 days |
| 15 Aug 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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).
Where it was distributed
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.
Questions about this recall
Is Cobas KRAS Mutation Test for In Vitro Diagnostic Use recalled?
Yes. Roche Molecular Systems recalled Cobas KRAS Mutation Test for In Vitro Diagnostic Use on 24 Feb 2012. The recall is Class III and its status is Terminated. Recall number Z-2159-2012.
Why was it recalled?
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
Which lots are affected?
05852170190; Lot P06778
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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