cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
FDA Device Recall #Z-0083-2022 — Class II — September 3, 2021
Recall Summary
| Recall Number | Z-0083-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 3, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Roche Molecular Systems, Inc. |
| Location | Branchburg, NJ |
| Product Type | Devices |
| Quantity | 507 US; 6,676 ex- US |
Product Description
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Reason for Recall
False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Canada, UK, Poland, Spain, Italy, Sweden, Greece, Denmark, Norway, Netherlands, France, Czech Republic, Belgium, Austria, Slovakia, Hungary, Switzerland, Lithuania, Slovenia. Serbia, North Macedonia, Myanmar, Lebanon, Russia, Croatia, Morocco, Kazakhstan, Dominican Republic, Israel, El Salvador, Vietnam, Malaysia, Taiwan, China, Japan, Hong Kong, Korea, Brazil, Philippines, Thailand, Chile, Colombia, Singapore, Argentina, Australia, India, Uruguay, Ecuador, Panama, Costa Rica, Pakistan, Peru, Indonesia, New Zealand.
Lot / Code Information
All lot numbers
Other Recalls from Roche Molecular Systems, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1106-2023 | Class II | cobas Influenza A/B & RSV UC (Utility Channel) ... | Dec 21, 2022 |
| Z-1104-2023 | Class II | cobas SARS-CoV-2 & Influenza A/B Qualitative as... | 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.