Device 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
Z-1984-2026
Product summary
- Event
- Event 98702
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 101 units
- Official record key
device-enforcement:Z-1984-2026
Official wording
Reason: Neutralization Buffer may contain contaminants
Code information: Lot: F5061154/UDI: 00816387021091
Distribution pattern: US Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.
Derived failure modes
-
Unknown
Neutralization Buffer may contain contaminants