BioMérieux VIDAS CMV IgM 30-Test Kits: Invalid Calibrations Risk
BioMérieux recalls VIDAS CMV IgM 30-test kits with invalid calibrations that may cause inaccurate results. Affected lots expire June 2022.
Lower-risk recall
Invalid calibrations (out of range high) while using the product.
Contact the company
What happened, in plain English
BioMérieux is recalling VIDAS CMV IgM 30-test kits that may have invalid calibrations, leading to inaccurate results. This could affect medical testing for CMV infections. Read more at govinfonow.com/recall/61168-biom-rieux-vidas-cmv-igm-30-test-kits-invalid-calibrations.
Source Summary by GovInfoNow · govinfonow.com/recall/61168-biom-rieux-vidas-cmv-igm-30-test-kits-invalid-calibrations · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0742-2022
Cite this page
“BioMérieux VIDAS CMV IgM 30-Test Kits: Invalid Calibrations Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61168-biom-rieux-vidas-cmv-igm-30-test-kits-invalid-calibrations. Based on FDA recall #Z-0742-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0742-2022%22&limit=1).
Why it’s dangerous
The kits may have calibrations outside the acceptable range, causing inaccurate test results. This could lead to incorrect conclusions about CMV infections, especially in critical medical decisions.
Who’s affected
Healthcare providers using these kits for CMV testing are affected. Patients relying on accurate test results may be at risk of incorrect diagnoses.
How to tell if you have this one
Check for lot number 1008873260 on the kit packaging. These kits were sold with an expiration date of June 2:2022.
- Brand
BioMérieux- Category
Medical device
What to do — step by step
Check Kit Lot Number
Look for lot number 1008873260 on the product packaging.
Where it went and when
Where it was distributed
Distributed in 18 states, and outside the U.S.
FDA distribution: “Distribution was made to CA, FL, GA, IL, IN, LA, MA, MD, ME, MO, NJ, NY, OH, PA, TX, VA, WI, and WV. There was government distribution but no military or foreign distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Georgia, Illinois, Indiana, Louisiana, Maine, Maryland, Massachusetts, Missouri, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 4.1 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-0742-2022 (February 9, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0742-2022 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.