Lower riskMedical device recall · FDA · Published September 3, 2021
Roche cobas EGFR Mutation Test v2 may give false results for Ex20Ins mutations
Roche recalls cobas EGFR Mutation Test v2 due to false mutation results for Ex20Ins mutations, potentially leading to incorrect cancer treatment decisions. Affected units include all lot numbers of the system.
False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
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Contact the company
📍Recalling firmRoche Molecular Systems, Inc.1080 US Highway 202 S · Branchburg, NJ 08876-3733
✎ GovInfoNow plain-language explainer
Roche is recalling its cobas EGFR Mutation Test v2 system because it can produce false results for Ex20Ins mutations, which might lead to incorrect cancer treatments. This affects all units of the system sold with the catalog number 07248563190. Read more at govinfonow.com/recall/61832-roche-cobas-egfr-mutation-test-v2-may-give-false-results.
“Roche cobas EGFR Mutation Test v2 may give false results for Ex20Ins mutations.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61832-roche-cobas-egfr-mutation-test-v2-may-give-false-results. Based on FDA recall #Z-0083-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0083-2022%22&limit=1).
Roche Molecular Systems, Inc. recalled the cobas EGFR Mutation Test v2-Somatic gene mutation detection system (Catalog Number 07248563190) on Sept. 3, 2021, according to the FDA. The device may produce false mutation detected results for exon 20 insertion mutations, potentially leading to inappropriate treatment.
How to tell if you have it
Brand: Roche
Product: cobas EGFR Mutation Test v2-Somatic gene mutation detection system
Catalog Number: 07248563190
Lot numbers: All lot numbers
The hazard
The recall cites a hazard where the cobas EGFR Mutation Test v2 may detect false mutations for the exon 20 insertion (Ex20Ins), which may lead to inappropriate treatment. The official record does not report specific incidents or injuries.
Context
GovInfoNow's records show Roche Molecular Systems, Inc. has 10 other recalls on record since Oct. 27, 2017. Other recent recalls of similar products include the Roche cobas SARS-CoV-2 & Flu A/B tests (Dec. 21, 2022), the Roche cobas 5800 PCR device (Sept. 8, 2022), and the Roche cobas LiatSystem (Nov. 16, 2021). Additional recent recalls of similar products include the Roche cobas pro integrated solutions (Jan. 20, 2026), the Roche Elecsys Anti-TSHR Assay (Nov. 21, 2025), and the Exploro Fertility Test (Nov. 22, 2025).
How to tell if you have this one
Check for the cobas EGFR Mutation Test v2 system with catalog number 07248563190. All lot numbers are affected by this recall.
Brand
Roche
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the catalog number 07248563190 on the system to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0083-2022 (September 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0083-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.