Immuno-Mycologics, Inc FDA Recalls

3 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens Class IIMar 26, 2026Neutralization Buffer may contain contaminants	Neutralization Buffer may contain contaminants	Class IIDevices	Mar 26, 2026
Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & ImmunodiffuClass IIFeb 10, 2025Candida Immunodiffusion Antigen may have reduced sensitivity	Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.	Class IIDevices	Feb 10, 2025
CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum andClass IIJan 3, 2022The firm found immunoassay products used to detect cryptococ	The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to ha	Class IIDevices	Jan 3, 2022