Recall Z-1984-2026— Immuno-Mycologics, Inc

Class II · Ongoing

Class II FDA medical device recall by Immuno-Mycologics, Inc, initiated 2026-03-26. FDA's recall record names no specific 510(k) clearance for this event. 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: Neutralization Buffer may contain contaminants.

Recalling firm
Immuno-Mycologics, Inc
Classification
Class II
Status
Ongoing
Initiated
2026-03-26
Firm location
Norman, OK, United States

Product 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 for recall

Neutralization Buffer may contain contaminants

Data sourced from openFDA. This site is unofficial and independent of the FDA.