FDA Device recall Z-0732-2019
PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening…
- FDA Device
- Class II
- terminated
- Published 2019-01-23
On 2019-01-23 the FDA classified a Class II recall of PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening… by Meridian Bioscience, citing 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 patie….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0732-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-17 |
| Published | 2019-01-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Meridian Bioscience |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot Numbers: 602096K089, 602096K090, 602096K091 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0732-2019%22
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