FDA DevicesClass II
Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-6...
Published: May 6, 2026Recall ID: Z-1984-2026Category: devicesCountry: US
Reason for Recall / Hazard
Neutralization Buffer may contain contaminants
Product Description & Identification
Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
Affected Products
Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
Additional Source Details
| Field | Value |
|---|---|
| City | Norman |
| State | OK |
| Event id | 98702 |
| Address 1 | 2701 Corporate Centre Dr |
| Code info | Lot: F5061154/UDI: 00816387021091 |
| Postal code | 73069-2901 |
| Report date | 20260506 |
| Product type | Devices |
| Product quantity | 101 units |
| Reason for recall | Neutralization Buffer may contain contaminants |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260326 |
| Center classification date | 20260429 |
Overview
- Recalling FirmImmuno-Mycologics, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.