Z-0732-2019Class II

PREMIER Cryptococcal Antigen, Catalog Number 602096

Name: Z-0732-2019 PREMIER Cryptococcal Antigen, Catalog Number 602096
Creator: Meridian Bioscience Inc
Published: 2018-12-17
License: https://open.fda.gov/license/

Meridian Bioscience Inc / initiated 2018-12-17 / Terminated

FDA source

Meridian Bioscience Inc began a recall of PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening or a... on 2018-12-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0732-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-17
Posted: 2019-01-14
Terminated: 2020-04-30
Recalling firm: Meridian Bioscience Inc
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).
Product code: MDU Antigen, Elisa, Cryptococcus
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.
FDA root cause: Unknown/Undetermined by firm
Action: Urgent: Voluntary Medical Device Recall notification letters dated 12/17/18 were distributed to customers. The letter identified the affected product, problem and actions to be taken. The letters instructed customers to review inventory for affected lots, forward the letter to any customers, contact the firm replacement product, complete the response form. For questions contact Meridian's Technical Service Department by telephone at 800-343-3858 or 513-271-3700 or by facsimile 513-272-5432.
Quantity in commerce: 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.
Product codes and lots: Lot Numbers: 602096K089, 602096K090, 602096K091

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0732-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0732-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-23	2019-01-14

Product code MDU

K904393Class IIPremier-Cryptococcal AntigenMeridian Diagnostics, Inc. / cleared 1991-01-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)