Z-1389-2025 Class II Ongoing
FDA device recall Z-1389-2025 was initiated by Immuno-Mycologics, Inc on February 10, 2025 and is designated Class II. Reason for recall: Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results. The recall status is ongoing. Affected quantity: 30 vials.
Recall Details
- Product Type
- Devices
- Report Date
- March 26, 2025
- Initiation Date
- February 10, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 vials
Product 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
Reason for Recall
Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of CA and OK and the countries of Peru France, Austria, Venezuela.
Code Information
Lot #: F4171005/UDI: 00816387020223