Class II

Medical Device Recall: Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis

Immuno-Mycologics, Inc · March 26, 2026

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.

States Affected

NATIONWIDE

Quantity Affected

101 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1984-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Immuno-Mycologics, Inc Medical Device Recall: Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis | SafeCheck