PREMIER Cryptococcal Antigen — Class II medical device recall Z-0732-2019
Terminated recall by Meridian Bioscience Inc, reported 2019-01-23, distributed nationwide. An enzyme reagent included in the kit is not maintaining stability through claimed product expiration, resulti
| Recall number | Z-0732-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Meridian Bioscience Inc, Cincinnati, OH, United States |
| Recall initiated | 2018-12-17 |
| Classified | 2019-01-14 |
| Reported by FDA | 2019-01-23 |
| Terminated | 2020-04-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | IN, IT |
| Quantity | 184 |
| Reason classes | specification failure |
| Lot numbers | 602096K089, 602096K090, 602096K091 |
| Model numbers | 602096 |
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).
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0732-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.