Class II — Meridian Bioscience Inc
| Recalling firm | MERIDIAN BIOSCIENCE, INC. |
|---|---|
| Registered facility | MERIDIAN BIOSCIENCE, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | 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 |
| 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. |
| Initiated | 2018-12-17 |
| Classified | 2019-01-14 |
| Terminated | 2020-04-30 |
| Recall number | Z-0732-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Meridian Bioscience Inc (Z-0732-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81787/
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