medical Class II Updated 2019-01-23

Meridian Bioscience Inc recalls PREMIER Cryptococcal Antigen, Catalog Number 602096 Produ

Recalled 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).


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 602096K089, 602096K090, 602096K091
View official government recall

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