Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusio

FDA device recall Z-1389-2025 · posted 2025-03-18 · Open, Classified

Recall details

Recalling firm

Immuno-Mycologics, Inc

Reason for recall

Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.

Action taken

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 electronically and attach to an email. Return the completed form to IMMY using one of the methods below: o Email: customerservice@immy.com; Mail to: Attn: Hunter Conover IMMY, Inc., 2701 Corporate Centre Dr., Norman, OK USA 73069 3. Ensure relevant staff members are informed of this recall, including relevant clinicians. Clinicians should review all negative results. 4. If you have supplied any potentially affected product to another organization, please advise that organization of this recall and send them this notification. Please contact us so we can follow up with them. 5. In case product is in transit, display this letter in a prominent place for one month.

Root cause

Process change control

Status

Open, Classified

Product code

GMI

Quantity affected

30 vials

Distribution

Worldwide - US Nationwide distribution in the states of CA and OK and the countries of Peru France, Austria, Venezuela.

Date initiated

2025-02-10

Date posted

2025-03-18

Location

Norman, OK