Roche Elecsys Anti-HAV IgM Assay Recall: Erroneous Software Setting

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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 its Elecsys Anti-HAV IgM assay kit because a software update error could lead to inaccurate hepatitis A virus test results. This affects lab tests that detect IgM antibodies in blood samples.

Why it’s dangerous

The software version 06.05-101 has an incorrect Border Area setting (1.0 1.00) instead of (0.90 1.10), which can cause inaccurate test results. This error may lead to false negatives or positives in hepatitis A virus detection.

Who’s affected

Laboratories using the Elecsys Anti-HAV IgM assay kit with the specific software version (06.05-101) are affected. Users most at risk are those conducting hepatitis A virus tests with this kit.

How to tell if you have this one

Check for the catalog number 07026773190 and software version 06.05-101 on the Elecsys Anti-HAV IgM assay kit. The recall applies to kits sold with this specific software version.

Brand
Roche
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify the software version on the Elecsys Anti-HAV IgM assay kit. The affected version is 06.05-101.

✎ GovInfoNow

Questions people ask

What is the specific software version that is affected?

The affected software version is 06.05-101.

How does this error affect test results?

The error causes an incorrect Border Area setting, which may lead to inaccurate hepatitis A virus test results.

What should labs do if they have the affected software version?

Labs should check the software version and contact Roche for guidance on next steps.

Take action

Contact Roche

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

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Subject: Recall Z-0669-2020 — Roche Roche

Hello,

I own a Roche that is covered by recall Z-0669-2020 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-0669-2020 (October 28, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0669-2020 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 Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM)

Lower-risk recall