Medical DeviceMay 6, 2026
Immuno-Mycologics Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF recall — FDA Z-1984-2026
Neutralization Buffer may contain contaminants
Class IIFDA: OngoingImmuno-Mycologics, Inc
Recall history in this database
Classification mix: Class II: 5.
Medical DeviceMar 26, 2025
Immuno-Mycologics Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal recall — FDA Z-1389-2025
Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
Class IIFDA: OngoingImmuno-Mycologics, Inc.
Medical DeviceFeb 9, 2022
Immuno-Mycologics CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the recall — FDA Z-0545-2022
The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to have reduced specificity (90% now versus 99% before). As a result, a small number…
Class IIFDA: TerminatedImmuno-Mycologics, Inc.
Medical DeviceJun 17, 2020
Immuno-Mycologics Histoplasma Immunodiffusion (ID) Antigen recall — FDA Z-2301-2020
False positive results due to potential contamination of reagent.
Class IIFDA: TerminatedImmuno-Mycologics, Inc.
Medical DeviceJul 18, 2018
Immuno-Mycologics Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product recall — FDA Z-2409-2018
Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results
Class IIFDA: TerminatedImmuno-Mycologics, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Immuno-Mycologics, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.