Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 20, 2021
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Roche Molecular Systems, Inc. recalled cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248… - a moderate-severity action.
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248… was recalled by Roche Molecular Systems, Inc. in October 20, 2021. Reason: False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutati…. Check the official notice for the remedy. Verify recall #Z-0083-2022 with the FDA Devices before acting.
The recall
Roche Molecular Systems, Inc. issued this moderate-severity FDA Devices recall-False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutati….
- Moderate
- severity level
- Class II
- classification
- October 20, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0083-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0083-2022) was formally reported on October 20, 2021, with the manufacturer initiating the action on September 3, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Roche Molecular Systems, Inc. is listed as the recalling firm, operating out of Branchburg, NJ. Federal records list the affected scope as 507 US; 6,676 ex- US.
The documented reason for this recall is: 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 data in the federal record shows the product reached: 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, Switz…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
507 US; 6,676 ex- US
Related Recalls
6
3 from same agency
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0083-2022 |
| Date reported | October 20, 2021 |
| Date initiated | September 3, 2021 |
| Recalling firm | Roche Molecular Systems, Inc. |
| Firm location | Branchburg, NJ |
| Affected scope | 507 US; 6,676 ex- US |
| 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, S… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0083-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190. Recalled by Roche Molecular Systems, Inc.. Units affected: 507 US; 6,676 ex- US.
Why was this product recalled? ▼
False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 20, 2021. Severity: Moderate. Recall number: Z-0083-2022.
Where was the recalled product distributed? ▼
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, 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0083-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 20, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.