FDA Device recall Z-1984-2026
Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium sp…
- FDA Device
- Class II
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class II recall of Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium sp… by Immuno Mycologics, citing neutralization Buffer may contain contaminants.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1984-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-26 |
| Published | 2026-05-06 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Immuno Mycologics |
| Distribution | US |
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
Neutralization Buffer may contain contaminants
Identifiers
| code_info | Lot: F5061154/UDI: 00816387021091 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1984-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.