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Immuno-Mycologics Recalls
7 recalls on record · June 29, 2016 to May 6, 2026 · Medical Devices
Recalls by year
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26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 6, 2026Medical DevicesFDA
Immuno-Mycologics, Inc recalls Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens
Hazard: Neutralization Buffer may contain contaminants
March 26, 2025Medical DevicesFDA
Immuno-Mycologics, Inc recalls Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffu
Hazard: Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
February 9, 2022Medical DevicesFDA
Immuno-Mycologics, Inc recalls CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and
Hazard: 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 of samples with positive test results may be false positives, which may cause some patients to initiate unnecessary anti-fungal therapy. Samples with negative test results are NOT affected.
June 17, 2020Medical DevicesFDA
Immuno-Mycologics, Inc recalls Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Posi
Hazard: False positive results due to potential contamination of reagent.
July 18, 2018Medical DevicesFDA
Immuno-Mycologics, Inc recalls Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an i
Hazard: Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results
February 8, 2017Medical DevicesFDA
Immuno-Mycologics, Inc recalls Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
Hazard: The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who reported false positive results.
June 29, 2016Medical DevicesFDA
Immuno-Mycologics, Inc recalls Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to
Hazard: The device was found to have bacterial contamination.