Histoplasma Immunodiffusion — Class II medical device recall Z-2301-2020
Terminated recall by Immuno-Mycologics, Inc, reported 2020-06-17, distributed nationwide. False positive results due to potential contamination of reagent.
| Recall number | Z-2301-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Immuno-Mycologics, Inc, Norman, OK, United States |
| Recall initiated | 2019-11-04 |
| Classified | 2020-06-09 |
| Reported by FDA | 2020-06-17 |
| Terminated | 2022-05-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | ES, FR, GB, HK |
| Quantity | 155 vials |
| UPC / GTIN / UDI-DI | 00816387020391 |
| Lot numbers | L106909 |
Product
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
Reason for recall
False positive results due to potential contamination of reagent.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2301-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.