Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PREMIER Cryptococcal Antigen Recalled by Meridian Bioscience Inc Due to An enzyme reagent included in the kit is...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Meridian Bioscience Inc directly.
Affected Products
PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrosoinal fluid (CSF).
Quantity: 184
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Meridian Bioscience Inc
Meridian Bioscience Inc has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report