Roche cobas c 311/501/502/Integra 400 Plus: RF interference with sTfR assays

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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Roche is recalling cobas c 311, c 501, c 502, and Integra 400 Plus analyzers because they may cause false results with sTfR assays due to RF interference. This could lead to inaccurate test outcomes for certain blood tests.

Why it’s dangerous

The analyzers may produce false positive or negative results for sTfR assays when there is RF interference. This interference can occur during specific testing conditions, potentially leading to incorrect diagnoses.

Who’s affected

Healthcare facilities using Roche analyzers with sTfR assays are affected. Patients receiving these tests may be at risk of inaccurate results.

How to tell if you have this one

Check for catalog number 20763454122 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 20763454122 on the analyzer or module.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

The analyzers may cause RF interference with sTfR assays, leading to inaccurate test results.

What should I do if I have this analyzer?

Check for catalog number 20763454122 on the analyzer or module. If affected, contact Roche for guidance.

Are there any safety risks?

The recall addresses potential inaccurate test results, not immediate physical harm. The risk level is low.

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-0108-2020 — Roche Roche

Hello,

I own a Roche that is covered by recall Z-0108-2020 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-0108-2020 (August 28, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0108-2020 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 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay

Lower-risk recall