Z-0732-2019 Class II Terminated
FDA device recall Z-0732-2019 was initiated by Meridian Bioscience Inc on December 17, 2018 and is designated Class II. 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 … The recall status is terminated (terminated April 30, 2020). Affected quantity: 184.
Recall Details
- Product Type
- Devices
- Report Date
- January 23, 2019
- Initiation Date
- December 17, 2018
- Termination Date
- April 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 184
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).
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.
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.
Code Information
Lot Numbers: 602096K089, 602096K090, 602096K091