Immuno-Mycologics, Inc

Complete recall history across all FDA and CPSC categories — 6 total recalls

Immuno-Mycologics, Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (6)

FDA medical device enforcement actions by Immuno-Mycologics, Inc

Date Product Reason Class
Feb 10, 2025 Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal... Candida Immunodiffusion Antigen may have reduced sensitivity which could resu... Class II
Jan 3, 2022 CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Det... The firm found immunoassay products used to detect cryptococcal antigen in se... Class II
Nov 4, 2019 Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple pr... False positive results due to potential contamination of reagent. Class II
Mar 30, 2018 Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product... Potential for LFA strips to improperly wick which may cause false negative cr... Class II
Dec 27, 2016 Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003 The affected products have approximately a 91% specificity while the non-affe... Class II
May 9, 2016 Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal ... The device was found to have bacterial contamination. Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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