Roche cobas c 701/702 Analyzers: RF interference with sTfR assays
Roche recalls cobas c 701 and 702 analyzers due to potential RF interference with sTfR assays. Affected units have catalog number 05950821190 and all serial numbers.
Lower-risk recall
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What happened, in plain English
Roche is recalling cobas c 701 and 702 analyzers because they may give inaccurate results for sTfR assays due to RF interference. This could lead to incorrect medical diagnoses if used without the recall fix. Read more at govinfonow.com/recall/67094-roche-cobas-c-701-702-analyzers-rf-interference-with-stfr.
Source Summary by GovInfoNow · govinfonow.com/recall/67094-roche-cobas-c-701-702-analyzers-rf-interference-with-stfr · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0109-2020
Cite this page
“Roche cobas c 701/702 Analyzers: RF interference with sTfR assays.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67094-roche-cobas-c-701-702-analyzers-rf-interference-with-stfr. Based on FDA recall #Z-0109-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0109-2020%22&limit=1).
Why it’s dangerous
The analyzers may produce incorrect results for sTfR (soluble transferrin receptor) assays due to interference from rheumatoid factors. This could lead to wrong medical diagnoses if the tests are not properly corrected.
Who’s affected
Healthcare labs using cobas c 701 or 702 analyzers with catalog number 05950821190 are affected. Lab technicians and medical staff who run these tests are most at risk of inaccurate results.
How to tell if you have this one
Check for the catalog number 05950821190 on the analyzer or module. All serial numbers are affected by this recall.
- Brand
Roche- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0108-2020 | cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122; All serial numbers | 6,494 units |
| Z-0109-2020 | cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190; All serial numbers | 1,086 units |
What to do — step by step
Check for Catalog Number
Look for catalog number 05950821190 on the analyzer or module.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using my analyzer immediately?
The recall does not require immediate stop use; labs can continue using the analyzers but should check for the catalog number and follow the recall steps.
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Where this comes from
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-0109-2020 (August 28, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0109-2020 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.