FDA Enforcement
Class II
Ongoing
Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
Recall: Z-1984-2026
·
Reported May 6, 2026
Enforcement
- Recall Number
- Z-1984-2026
- Event ID
- 98702
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Immuno-Mycologics, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- May 6, 2026
- Initiation Date
- March 26, 2026
- Classification Date
- April 29, 2026
- Address
- 2701 Corporate Centre Dr, Norman, OK, 73069-2901, United States
Description
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
Code Info
Lot: F5061154/UDI: 00816387021091
Distribution
US Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.
Quantity
101 units