FDA Device recall Z-2301-2020
Histoplasma Immunodiffusion (ID) Antigen
- FDA Device
- Class II
- terminated
- Published 2020-06-17
On 2020-06-17 the FDA classified a Class II recall of Histoplasma Immunodiffusion (ID) Antigen by Immuno Mycologics, citing false positive results due to potential contamination of reagent.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2301-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-04 |
| Published | 2020-06-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Immuno Mycologics |
| Distribution | US |
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
False positive results due to potential contamination of reagent.
Identifiers
| code_info | Lot number L106909; UDI # (01) 00816387020391 (17) 220610(10)L106909 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2301-2020%22
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