Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mu...

FDA Device Recall #Z-2159-2012 — Class III — February 24, 2012

Recall Summary

Recall Number Z-2159-2012
Classification Class III — Low risk
Date Initiated February 24, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Roche Molecular Systems, Inc.
Location Branchburg, NJ
Product Type Devices
Quantity 264 kits to 13 EU countries; 2 kits to Canada and 33 kits to 11 countries in the Rest of the World

Product Description

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).

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

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.

Lot / Code Information

05852170190; Lot P06778

Other Recalls from Roche Molecular Systems, Inc.

Recall # Classification Product Date
Z-1104-2023 Class II cobas SARS-CoV-2 & Influenza A/B Qualitative as... Dec 21, 2022
Z-1106-2023 Class II cobas Influenza A/B & RSV UC (Utility Channel) ... Dec 21, 2022
Z-1105-2023 Class II cobas SARS-CoV-2 & Influenza A/B Qualitative nu... Dec 21, 2022
Z-0097-2023 Class II cobas 5800 instrument, Material No. 08707464001... Sep 8, 2022
Z-0828-2022 Class II cobas LiatSystem, respiratory virus panel nucle... Nov 16, 2021

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.