Bio-Rad CMV IgM EIA Recall: Unusual Positivity Rates with Human IgM Antibodies
Bio-Rad recalls CMV IgM EIA diagnostic tests due to unusual increases in positivity rates with human IgM antibodies to cytomegalovirus. Affected lots may lead to inaccurate test results.
Lower-risk recall
Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
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What happened, in plain English
Bio-Rad is recalling CMV IgM EIA diagnostic tests because they show unusually high positivity rates with human IgM antibodies to cytome: 1. The recall affects specific lots (B02022, E10022, G05022) of the CMV IgM EIA test. 2. This could lead to inaccurate test results, potentially causing incorrect health assessments. Read more at govinfonow.com/recall/59872-bio-rad-cmv-igm-eia-recall-unusual-positivity-rates-with.
Source Summary by GovInfoNow · govinfonow.com/recall/59872-bio-rad-cmv-igm-eia-recall-unusual-positivity-rates-with · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0342-2023
Cite this page
“Bio-Rad CMV IgM EIA Recall: Unusual Positivity Rates with Human IgM Antibodies.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59872-bio-rad-cmv-igm-eia-recall-unusual-positivity-rates-with. Based on FDA recall #Z-0342-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0342-2023%22&limit=1).
Why it’s dangerous
The test shows higher than expected positivity rates with human IgM antibodies to cytomegalovirus. This could lead to false positive results, potentially causing unnecessary concern or incorrect health decisions.
Who’s affected
Healthcare providers and labs using the recalled CMV IgM EIA tests may be affected. Individuals relying on these tests for cytomegalovirus detection could face inaccurate results.
How to tell if you have this one
Check the lot numbers on the test: B02022, E10022, or G05022. The product is a CMV IgM EIA in vitro diagnostic test from Bio-Rad Laboratories.
- Brand
Bio-Rad- Category
Medical device
What to do — step by step
Check Lot Numbers
Verify the lot number on the test to see if it matches B02022, E10022, or G05022.
Where it went and when
Where it was distributed
Distributed in 14 states.
FDA distribution: “U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Florida, Georgia, Hawaii, Iowa, Massachusetts, Minnesota, New Hampshire, New Jersey, North Carolina, Pennsylvania, Tennessee, Texas.
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of serious injury from this test?
No, the hazard is limited to potential inaccurate test results, not physical harm.
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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-0342-2023 (October 19, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0342-2023 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.