Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebral spinal fluid (CSF). The CrAg Lateral Flow Assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot/Serial Numbers: L102802 and L103012
- 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:
- Immuno-Mycologics, Inc
- Reason for Recall:
- Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebral spinal fluid (CSF). The CrAg Lateral Flow Assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis.
Product Codes/Lot Numbers:
Lot/Serial Numbers: L102802 and L103012
Distribution:
Distributed in: AM, PM
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2409-2018
Related Recalls
Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to have reduced specificity (90% now versus 99% before). As a result, a small number of samples with positive test results may be false positives, which may cause some patients to initiate unnecessary anti-fungal therapy. Samples with negative test results are NOT affected.
False positive results due to potential contamination of reagent.