Medical device recalls Moderate risk

Immuno-Mycologics, Inc recalls Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens…

Recall date
March 26, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1984-2026
FDA classification
Class II
Brand / firm
Immuno-Mycologics, Inc
Sold / distributed
US Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.

Why it was recalled

Neutralization Buffer may contain contaminants

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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