FDAFDA · Food and drugs·Recall number Z-0732-2019
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).
Published January 23, 2019 · Recall initiated: December 17, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Meridian Bioscience Inc
- Distributor
- 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.
- Lot
- Lot Numbers: 602096K089, 602096K090, 602096K091
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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