Lower risk Medical device recall · FDA · Published September 22, 2021

bioMerie: VIDAS RUB IgG (RBG) test may cause delayed results due to substrate error

bioMerieux recalls VIDAS RUB IgG (RBG) tests with specific lot numbers for potential delayed results due to a substrate error that prevents proper testing.

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

🇺🇸 FDA recall #Z-0432-2022Medical device bioMerieux ›

Lower-risk recall

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

Take action

Contact the company

Recalling firmbioMerieux, Inc.100 Rodolphe St · Durham, NC 27712-9402

✎ GovInfoNow plain-language explainer

bioMerieux is recalling VIDAS RUB IgG (RBG) tests with certain lot numbers because a substrate error can cause the test to fail, requiring users to run another test and delaying results. Read more at govinfonow.com/recall/61760-biomerie-vidas-rub-igg-rbg-test-may-cause-delayed-results.

Source Summary by GovInfoNow · govinfonow.com/recall/61760-biomerie-vidas-rub-igg-rbg-test-may-cause-delayed-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0432-2022

Cite this page

“bioMerie: VIDAS RUB IgG (RBG) test may cause delayed results due to substrate error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61760-biomerie-vidas-rub-igg-rbg-test-may-cause-delayed-results. Based on FDA recall #Z-0432-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0432-2022%22&limit=1).

The FDA announced on Sept. 22, 2021, that bioMerieux, Inc. is voluntarily recalling VIDAS RUB IgG (RBG) REF 30226 due to a substrate error. This defect prevents the test from running, potentially delaying results for users.

How to tell if you have it

Brand: bioMerieux
Product: VIDAS RUB IgG (RBG), REF 30226
UDI: 03573026138585
Lot codes: 1008694980, 1008700260, 1008828980
Distribution: US Nationwide

The hazard

The recall addresses complaints linked to a VIDAS substrate error that prevents the test from being run. This issue leads to potential delayed results because users must run another test.

Context

GovInfoNow's records show Biomerieux Inc has 36 other recalls on record since July 12, 2017. Recent similar recalls include the Bioporto ProNephro AKI Reagent Kit Recall (May 18, 2026) and Vivoo Protein Test Recall (Nov. 22, 2025).

How to tell if you have this one

Check the lot number on the test packaging. The affected lots are 1008694980, 1008700260, and 1008828980. The product is sold under the VIDAS RUB IgG (RBG) name with reference number 30226.

Brand
bioMerieux
Category
Medical device

FDA recall event · 16 products

All 16 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
Ongoing
Distribution
US Nationwide distribution.

Recall number	Product, codes & lots	Quantity
Z-0424-2022	VIDAS PRG Progesterone, REF 30409-01; UDI 03573026064952, Lot #s: 1008685490, 1008766980, 1008775630, 1008873180, 1008911240	1818 units
Z-0425-2022	VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01; UDI 03573026229146, Lot #s: 1008730880	50
Z-0426-2022	VIDAS Clostridium Difficile GDH, REF 30125-01; UDI 03573026444204, Lot #s: 1008686690	50
Z-0427-2022	VIDAS DEX@, Dimer Exclusion II, REF 30455-01; UDI 03573026387006, Lot #s: 1008696660,1008761020, 1008864290, 1008891690	1579
Z-0428-2022	VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01; UDI 03573026223601, Lot #s: 1008603580, 1008748010, 1008888030, 1008584190, 1008647850	28430
Z-0429-2022	VIDAS Mumps IgG (MPG), REF 30218; UDI 03573026064525, Lot #: 1008769120	One lot
Z-0430-2022	VIDAS Measles IgG (MSG), REF 30219; UDI 03573026064532, Lot #: 1008890110	One lot
Z-0431-2022	VIDAS TOXO IgG Avidity (TXGA), REF 30222-01; UDI 03573026263010, Lot #: 1008861590	One lot
Z-0432-2022	VIDAS RUB IgG (RBG), REF 30226; UDI 03573026138585, Lot #: 1008694980, 1008700260, 1008828980	Three lots
Z-0433-2022	VIDAS LH, REF 30406-01; UDI 03573026156930, Lot #: 1008848600	One lot
Z-0434-2022	VIDAS FSH, REF 30407-01; UDI 03573026156947, Lot #: 1008781470	One lot
Z-0435-2022	VIDAS Estradiol II, REF 30431-01; UDI 03573026161637, Lot #: 1008757880	One lot
Z-0436-2022	VIDAS Lyme IgM II (LYM), REF 416436; UDI 03573026447151, Lot #: 1008636750, 1008768920, 1008857410	Three lots
Z-0437-2022	VIDAS Lyme IgG II (LYM), REF 417401; UDI 03573026458270, Lot #: 1008714880, 1008824220	Two lots
Z-0438-2022	VIDAS SARS-COV-2 IgM, Ref 423833-01; UDI 03573026620738, Lot #: 1008710950	One lot
Z-0439-2022	VIDAS SARS-COV-2 IgG, Ref 423834-01; UDI 03573026620745, Lot #: 1008671430, 1008763910	Two lots

Based on the official FDA remedy

What to do — step by step

Check Lot Number
Look for the lot number on the test packaging to determine if it is affected.

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 published this recall 3 months after the firm started it.

Sep 22, 2021Firm started the recall
Dec 28, 2021FDA classified it Class II
Jan 5, 2022Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/61760-biomerie-vidas-rub-igg-rbg-test-may-cause-delayed-results">bioMerie: VIDAS RUB IgG (RBG) test may cause delayed results due to substrate error (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-0432-2022 (September 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0432-2022 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.