Meridian Bioscience Inc: Medical Device Recall in 2019 - (Recall #: Z-0732-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: December 17, 2018

Date Posted: January 23, 2019

Recall Number: Z-0732-2019

Event ID: 81787

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.

Status: Terminated

Product Quantity: 184

Code Information:

Lot Numbers: 602096K089, 602096K090, 602096K091

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated