CLASS II ONGOING Device recall · Reported 26 Mar 2025 · FDA Enforcement Report
Candida ID Antigen, REAG, AG recalled by Immuno-Mycologics
Immuno-Mycologics is recalling Candida ID Antigen, REAG, AG, distributed nationwide in the US. The recall was initiated on 10 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1389-2025
- FDA event ID
- 96315
- Recalling firm
- Immuno-Mycologics, Norman, OK
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Feb 2025
- FDA classified
- 18 Mar 2025
- Reported
- 26 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 10 Feb 2025 | Recall initiated by company | |
| 18 Mar 2025 | Classified by FDA | +36 days |
| 26 Mar 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
Product as listed by the FDA
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
Where it was distributed
Worldwide - US Nationwide distribution in the states of CA and OK and the countries of Peru France, Austria, Venezuela.
Questions about this recall
Why was it recalled?
Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
Which lots are affected?
Lot #: F4171005/UDI: 00816387020223
Where was it sold?
Worldwide - US Nationwide distribution in the states of CA and OK and the countries of Peru France, Austria, Venezuela.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Immuno-Mycologics
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