Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: F4171005/UDI: 00816387020223
- 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:
- Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE
Product Codes/Lot Numbers:
Lot #: F4171005/UDI: 00816387020223
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1389-2025
Related Recalls
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.
Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results