Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot number L106909; UDI # (01) 00816387020391 (17) 220610(10)L106909
- 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:
- False positive results due to potential contamination of reagent.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen
Product Codes/Lot Numbers:
Lot number L106909; UDI # (01) 00816387020391 (17) 220610(10)L106909
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2301-2020
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