Lower risk Medical device recall · FDA · Published October 28, 2019

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

Roche recalls Elecsys Anti-HAV IgM assay due to software error causing inaccurate hepatitis A test results. Affected units have specific catalog numbers and software versions.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0669-2020Medical device Roche ›

Lower-risk recall

Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous Border Area setting, (1.0 1.00) instead of (0.90 1.10).

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/66595-roche-elecsys-anti-hav-igm-assay-recall-erroneous-software-setting.

Source Summary by GovInfoNow · govinfonow.com/recall/66595-roche-elecsys-anti-hav-igm-assay-recall-erroneous-software-setting · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0669-2020

Cite this page

“Roche Elecsys Anti-HAV IgM Assay Recall: Erroneous Software Setting.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66595-roche-elecsys-anti-hav-igm-assay-recall-erroneous-software-setting. Based on FDA recall #Z-0669-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0669-2020%22&limit=1).

The FDA announced on 2019-10-28 that Roche Diagnostics Operations, Inc. recalled the Elecsys Anti-HAV IgM assay due to a software defect causing erroneous Border Area settings. This may lead to incorrect test results for hepatitis A virus detection.

How to tell if you have it

Brand: Roche
Product: Elecsys Anti-HAV IgM assay
Catalog number: 07026773190
APP-file version: 06.05-101
Quantity: 712 units

The hazard

The current software version of the Anti-HAV IgM APP-file downloaded an erroneous Border Area setting of (1.0 1.00) instead of (0.90 1.10). According to the FDA, this defect affects the in vitro qualitative detection of IgM antibodies to hepatitis A virus in human serum and plasma.

Context

GovInfoNow's records show Roche Diagnostics Operations, Inc. has 32 other recalls on record since 2019-07-02. Recent brand recalls include a 2026-01-20 recall of Roche cobas pro integrated solutions for software defects and a 2025-11-21 recall of the Roche Elecsys Anti-TSHR Assay due to inconsistent results. Other recent recalls of similar products include the 2026-04-01 Aniara Diagnostica ZYMUTEST HIA IgG Kit Recall and the 2026-07-13 Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall.

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.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.7 years after the firm started it.

Oct 28, 2019Firm started the recall
Dec 12, 2019FDA classified it Class II
Dec 18, 2019Published in FDA’s Enforcement Report
Jun 28, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/66595-roche-elecsys-anti-hav-igm-assay-recall-erroneous-software-setting">Roche Elecsys Anti-HAV IgM Assay Recall: Erroneous Software Setting (GovInfoNow)</a>

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.