Roche cobas c 701/702 Analyzers: RF interference with sTfR assays

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Recalling firmRoche Diagnostics Operations, Inc.9115 Hague Rd, N/A · Indianapolis, IN 46256-1025

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✎ GovInfoNow plain-language explainer

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.

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

Based on the official FDA remedy

What to do — step by step

Check for Catalog Number
Look for catalog number 05950821190 on the analyzer or module.

✎ GovInfoNow

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.

What is the fix for this issue?

The official recall record does not specify a fix or remedy for this issue.

How can I confirm if my analyzer is affected?

Check for catalog number 05950821190 on the analyzer or module. All serial numbers are affected.

Take action

Contact Roche

We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0109-2020 — Roche Roche

Hello,

I own a Roche that is covered by recall Z-0109-2020 from Roche.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

Roche Diagnostics Operations, Inc. recalls cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190

Lower-risk recall