Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The… — Class II medical device recall Z-2040-2016
Terminated recall by Immuno-Mycologics, Inc, reported 2016-06-29, distributed nationwide. The device was found to have bacterial contamination.
| Recall number | Z-2040-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Immuno-Mycologics, Inc, Norman, OK, United States |
| Recall initiated | 2016-05-09 |
| Classified | 2016-06-20 |
| Reported by FDA | 2016-06-29 |
| Terminated | 2017-01-10 |
| Distributed | Nationwide (US) |
| Quantity | 467 units |
| Reason classes | microbial contamination |
| Lot numbers | 111WH3 |
| Model numbers | H30150 |
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 for recall
The device was found to have bacterial contamination.
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-2040-2016. 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.