Immy — Class II medical device recall Z-1984-2026
Ongoing recall by Immuno-Mycologics, Inc, reported 2026-05-06, distributed nationwide. Neutralization Buffer may contain contaminants
| Recall number | Z-1984-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Immuno-Mycologics, Inc, Norman, OK, United States |
| Recall initiated | 2026-03-26 |
| Classified | 2026-04-29 |
| Reported by FDA | 2026-05-06 |
| Distributed | Nationwide (US) |
| Quantity | 101 units |
| UPC / GTIN / UDI-DI | 00816387021091 |
| Lot numbers | F5061154 |
| Model numbers | TBPN67-60 |
Product
Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
Reason for recall
Neutralization Buffer may contain contaminants
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-1984-2026. 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.