FDA recall Z-1984-2026

Immuno-Mycologics, Inc · Class II · 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

Reason for recall

Neutralization Buffer may contain contaminants

Distribution

US Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.

Key facts

Status
Ongoing
Initiation date
2026-03-26
Report date
2026-05-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Norman, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1984-2026