Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL recallZ-1389-2025 · Immuno-Mycologics, Inc · initiated Feb 10, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Immuno-Mycologics, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
FDA root cause category: Process change control
What the company is doing
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: [email protected]; 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.
Recall details
- Recall number
- Z-1389-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 10, 2025
- Posted by the FDA
- Mar 18, 2025
- Recalling firm
- Immuno-Mycologics, Inc
- Quantity
- 30 vials
- Product code
- GMI
- Distribution
- Worldwide - US Nationwide distribution in the states of CA and OK and the countries of Peru France, Austria, Venezuela.
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
Code information (models, lots, serial numbers)
Lot #: F4171005/UDI: 00816387020223
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IMMY C50110Immuno-Mycologics, Inc. · Candida Species, Antibody Detection1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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