Warning
Immuno-Mycologics Recalls Immy
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1984-2026Medical Device
Immuno-Mycologics Recalls Immy
Immuno-Mycologics, Inc · Class II — Moderate Risk
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
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class II FDA recall has been issued for a medical device from Immuno-Mycologics, Inc, initiated on March 26, 2026. Neutralization Buffer may contain contaminants. This recall covers 101 units, distributed in AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA. While not the highest severity, consumers should exercise caution and stop using the product until the recall is resolved.
Sources: FDA openFDA Enforcement Database
This recall appears in: Other Injury Hazards.