CLASS II Device recall · Reported 17 Jun 2020 · FDA Enforcement Report
Histoplasma Immunodiffusion (ID) Antigen recalled by Immuno-Mycologics
Immuno-Mycologics is recalling Histoplasma Immunodiffusion (ID) Antigen, distributed nationwide in the US. The recall was initiated on 4 Nov 2019 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-2301-2020
- FDA event ID
- 85368
- Recalling firm
- Immuno-Mycologics, Norman, OK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Nov 2019
- FDA classified
- 9 Jun 2020
- Reported
- 17 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 4 Nov 2019 | Recall initiated by company | |
| 9 Jun 2020 | Classified by FDA | +218 days |
| 17 Jun 2020 | 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
False positive results due to potential contamination of reagent.
Product as listed by the FDA
Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen
Where it was distributed
Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, FL, IL, IN, MI, MN, NY,TX, UT, VA, WI and the countries of France, Spain, Hong Kong, United Kingdom.
Nationwide ArizonaCaliforniaFloridaIllinoisIndianaMichiganMinnesotaNew YorkTexasUtahVirginiaWisconsin
Questions about this recall
Why was it recalled?
False positive results due to potential contamination of reagent.
Which lots are affected?
Lot number L106909; UDI # (01) 00816387020391 (17) 220610(10)L106909
Where was it sold?
Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, FL, IL, IN, MI, MN, NY,TX, UT, VA, WI and the countries of France, Spain, Hong Kong, United Kingdom.
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.
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