Recall Z-1389-2025— Immuno-Mycologics, Inc
Class II · Ongoing
Class II FDA medical device recall by Immuno-Mycologics, Inc, initiated 2025-02-10. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results..
- Recalling firm
- Immuno-Mycologics, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-02-10
- Firm location
- Norman, OK, United States
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.
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