Device product
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
Z-1389-2025
Product summary
- Event
- Event 96315
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 30 vials
- Official record key
device-enforcement:Z-1389-2025
Official wording
Reason: Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
Code information: Lot #: F4171005/UDI: 00816387020223
Distribution pattern: Worldwide - US Nationwide distribution in the states of CA and OK and the countries of Peru France, Austria, Venezuela.
Derived failure modes
-
Unknown
Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.