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).
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: 602096K089, 602096K090, 602096K091
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Meridian Bioscience Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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 Codes/Lot Numbers:
Lot Numbers: 602096K089, 602096K090, 602096K091
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0732-2019
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