Lower riskMedical device recall · FDA · Published December 17, 2018
Meridian Bioscience PREMIER Cryptococcal Antigen Kit May Give False Negatives
Meridian Bioscience recalls PREMIER Cryptococcal Antigen enzyme immunoassay kits with catalog number 602096 due to potential false negative results from unstable enzyme reagents.
An enzyme reagent included in the kit is not maintaining stability through claimed product expiration, resulting in the potential for false negative results when tested with patient specimens and the positive control.
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Contact the company
📍Recalling firmMeridian Bioscience Inc3471 River Hills Dr · Cincinnati, OH 45244-3023
✎ GovInfoNow plain-language explainer
Meridian Bioscience is recalling PREMIER Cryptococcal Antigen enzyme immunoassay kits because the enzyme reagent may degrade over time, causing false negative test results. This could lead to incorrect diagnoses of cryptococcal infections, which are serious fungal infections that can affect the brain and spinal cord. Read more at govinfonow.com/recall/69324-meridian-bioscience-premier-cryptococcal-antigen-kit-may-give-false-negatives.
“Meridian Bioscience PREMIER Cryptococcal Antigen Kit May Give False Negatives.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69324-meridian-bioscience-premier-cryptococcal-antigen-kit-may-give-false-negatives. Based on FDA recall #Z-0732-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0732-2019%22&limit=1).
The FDA announced on 2018-12-17 that Meridian Bioscience Inc recalled PREMIER Cryptococcal Antigen enzyme immunoassay kits due to potential false negative results, according to the FDA. The hazard stems from an enzyme reagent failing to maintain stability through the claimed expiration date.
How to tell if you have it
Brand: Meridian Bioscience
Product: PREMIER Cryptococcal Antigen enzyme immunoassay
Catalog Number: 602096
Lot Numbers: 602096K089, 602096K090, 602096K091
The hazard
An enzyme reagent included in the kit is not maintaining stability through claimed product expiration, resulting in the potential for false negative results when tested with patient specimens and the positive control, according to the FDA.
Context
GovInfoNow's records show Meridian Bioscience Inc has had 8 other recalls on record since 2021-02-08. Other recent recalls of similar products include Meridian Bioscience Revogene C. difficile Test Recall (2025-12-05), Meridian Bioscience Group B Strep Test Kit Recall (2025-10-07), and Meridian Bioscience Para-Pak Clean Vial Recall (2023-10-19). Other recent recalls of similar products include Magellan LeadCare II Blood Lead Test Kits (2026-03-13), Magellan LeadCare Plus Blood Lead Test Kit (2026-03-13), and Magellan LeadCare Ultra Blood Lead Test Kit (2026-03-13).
How to tell if you have this one
Check for the catalog number 602096 on the kit. The affected lots are 602096K089, 602096K090, and 602096K091.
Brand
Meridian Bioscience
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for the lot numbers 602096K089, 602096K090, or 602096K091 on the kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 17 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide Distribution - US Nationwide in the states of: AK, CA, CO, DE, IL, KS, KY, LA, MD, MO, NC, ND, NJ, NY, SC, TX, and VA. The products were distributed to the following foreign countries: India and Italy.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, California, Colorado, Delaware, Illinois, Kansas, Kentucky, Louisiana, Maryland, Missouri, New Jersey, New York, North Carolina, North Dakota, South Carolina, Texas, Virginia.
Recall timeline
FDA terminated this recall 16 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-0732-2019 (December 17, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0732-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.