Recall Z-1389-2025 ยท GMI Antigen, Cf And / Or Id, Coccidioides Immitis
Immuno-Mycologics, Inc
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
| Date | Mar 18, 2025 (initiated Feb 10, 2025) |
| Status | Open, Classified |
| Reason | Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results. |
| Root cause | Process change control |
| Action | On February 10, 2025, Immy issued a "Urgent Medical Device Recall" Notification to affected consignees. Immy asked consignees to take the following actions: 1. Immediately identify, count, and segregate any affected vials you have in your inventory to prevent them from being used or shipped to your customers. As soon as possible, discard your affected inventory. 2. Complete the attached Acknowledgement and Receipt Form (pages 3 and 4 below) even if you do not have any affected stock remaining in your possession. Note: The form is a fillable PDF. You can save it to your computer, fill out ele |
| Quantity | 30 vials |
| Distribution | Worldwide - US Nationwide distribution in the states of CA and OK and the countries of Peru France, Austria, Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.