Z-1389-2025Class II

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

Name: Z-1389-2025 Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, &...
Creator: Immuno-Mycologics, Inc
Published: 2025-02-10
License: https://open.fda.gov/license/

IMMY, Inc. / initiated 2025-02-10 / Open, Classified

FDA source

Immuno-Mycologics, Inc began a recall of 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... on 2025-02-10. FDA classified it as Class II and gives the reason as "Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1389-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-10
Posted: 2025-03-18
Recalling firm: IMMY, Inc.
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
Product code: GMI Antigen, Cf And / Or Id, Coccidioides Immitis
Reason for recall: Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
FDA 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 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.
Quantity in commerce: 30 vials
Distribution: Worldwide - US Nationwide distribution in the states of CA and OK and the countries of Peru France, Austria, Venezuela.
Product codes and lots: Lot #: F4171005/UDI: 00816387020223

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1389-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1389-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-18

Product code GMI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)