Biomerieux VIDAS CMV IgM 30 Tests Recall: Calibration Issues
Biomerieux recalls VIDAS CMV IgM 30 Tests with calibration issues in specific lots. Affected units may give inaccurate results; stop using and contact for replacement.
Lower-risk recall
bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ; 30205-01).
Contact the company
What happened, in plain English
Biomerieux is recalling certain lots of VIDAS CMV IgM 30 Tests due to calibration problems that could lead to inaccurate results. This affects lab tests for CMV (cytomegalovirus) infections. Read more at govinfonow.com/recall/63057-biomerieux-vidas-cmv-igm-30-tests-recall-calibration-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/63057-biomerieux-vidas-cmv-igm-30-tests-recall-calibration-issues · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1408-2021
Cite this page
“Biomerieux VIDAS CMV IgM 30 Tests Recall: Calibration Issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63057-biomerieux-vidas-cmv-igm-30-tests-recall-calibration-issues. Based on FDA recall #Z-1408-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1408-2021%22&limit=1).
Why it’s dangerous
The calibration issues in specific lots can cause inaccurate test results for cytomegalovirus (CMV) infections. This may lead to incorrect diagnoses or treatment decisions.
Who’s affected
Lab users who purchased the recalled lots of VIDAS CMV IgM 30 Tests are affected. Healthcare professionals and labs using these specific lots for testing are most at risk.
How to tell if you have this one
Check for lot numbers 1008143230, 1008182270, 1008363970, or 1008433580 with expiration dates listed above. The product is sold under US reference 30205-01.
- Brand
Biomerieux- Category
Medical device
What to do — step by step
Check Product Lot Number
Look for lot numbers 1008143230, 1008182270, 1008363970, or 1008433580 on the test kit packaging.
Contact Biomerieux
Reach out to Biomerieux for a replacement or refund if you have the recalled lot numbers.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 20 states.
FDA distribution: “Distributed nationwide to NY, CA, IL, WV, NJ, NY, TX, IN, PA, WI, VA, GA, CO, MI, FL, OH, MA, LA, NV, MO, CT and internationally to Argentina, Australia, Belgium, Brazil, Switzerland, Chile, Colombia, Czech Republic, Germany, Egypt, Spain,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Missouri, Nevada, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 3.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1408-2021 (March 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1408-2021 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.