FDA Device recall Z-2040-2016
Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in…
- FDA Device
- Class II
- terminated
- Published 2016-06-29
On 2016-06-29 the FDA classified a Class II recall of Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in… by Immuno Mycologics, citing the device was found to have bacterial contamination.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2040-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-09 |
| Published | 2016-06-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Immuno Mycologics |
| Distribution | US |
Product
Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosis
Reason
The device was found to have bacterial contamination.
Identifiers
| code_info | Lot 111WH3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2040-2016%22
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