Lower riskMedical device recall · FDA · Published February 8, 2021
Meridian Bioscience ImmunoCard Mycoplasma EIA Recall: False negatives from incorrect
Meridian Bioscience recalls ImmunoCard Mycoplasma EIA kits that may give false-negative results if stored incorrectly, risking missed diagnosis of Mycoplasma pneumoniae infection.
Use of the kits after incorrect storage could lead to a potential false-negative or invalid result. In the event of a false-negative, the incorrect assumption would be made as to the cause of patient symptoms. The appropriate treatment may not be administered, and symptoms may progress. Additional evaluations will be completed and documented within the associated Health Hazard Evaluation.
Take action
Contact the company
📍Recalling firmMeridian Bioscience Inc3471 River Hills Dr · Cincinnati, OH 45244-3023
“Meridian Bioscience ImmunoCard Mycoplasma EIA Recall: False negatives from incorrect.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63293-meridian-bioscience-immunocard-mycoplasma-eia-recall-false-negatives-from-incorrect. Based on FDA recall #Z-1299-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1299-2021%22&limit=1).
The FDA announced on Feb. 8, 2021, that Meridian Bioscience Inc is recalling The ImmunoCard Mycoplasma EIA kits due to potential false-negative or invalid results from incorrect storage. Eight kits distributed in Ohio and South Carolina are affected by this voluntary Class II recall.
How to tell if you have it
Brand: Meridian Bioscience
Product: The ImmunoCard Mycoplasma EIA
Catalog Number: 709030
Lot Number: 709030M114
Device Identifier: 00840733101762
The hazard
Use of the kits after incorrect storage could lead to a potential false-negative or invalid result. In the event of a false-negative, the incorrect assumption would be made as to the cause of patient symptoms. The appropriate treatment may not be administered, and symptoms may progress.
Context
GovInfoNow's records show Meridian Bioscience Inc has had 8 other recalls on record since Dec. 17, 2018. Other recent recalls of similar products include the Revogene C. difficile Test Recall (Dec. 5, 2025), the Difficile Nucleic Acid Test Kit recall (Oct. 7, 2025), and the Clean Stool Transport System Recall (Oct. 19, 2023). Other recent recalls of similar products include the Immulite 2000 Syphilis Screen Recall (July 13, 2026), the Respiratory Panel 2.1 Recall (Oct. 22, 2025), and the Fertility Test Recall (Nov. 22, 2025).
How to tell if you have this one
Check for catalog number 709030, lot number 709030M114, or device identifier 00840733101762 on the kit packaging. The kits are intended for diagnosing recent Mycoplasma pneumoniae infections.
Brand
Meridian Bioscience
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Storage Conditions
Ensure the kits are stored correctly to avoid false-negative results.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of OH, SC.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Ohio, South Carolina.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1299-2021 (February 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1299-2021 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.