The Recall Desk

Manufacturer

Immuno-Mycologics, Inc

7 recalls in our database name Immuno-Mycologics, Inc as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
0
Severe
1
Most recent
2026-05-06

Of the 7 recalls from Immuno-Mycologics, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (14%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–7 of 7

  • SevereFDA (Devices)·Z-1984-2026·2026-05-06

    Immy Myco DDR Trident Neutralization Buffer B Recalled for Potential Contamination

    Immuno-Mycologics, Inc. is recalling Immy Myco DDR Trident Bulk Neutralization Buffer B (60 X 30 mL, Lot F5061154) because the product may contain contaminants. The buffer is used for clinical specimen processing for Mycobacterium spp. diagnosis.

    Product
    Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1389-2025·2025-03-26

    Candida ID Antigen recalled for reduced sensitivity, potential false negatives

    Immuno-Mycologics' Candida ID Antigen may have reduced sensitivity, causing false negative diagnostic results. Lot F4171005 has been distributed worldwide including CA and OK.

    Product
    Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0545-2022·2022-02-09

    Cryptococcal Antigen Test Kits Recalled for Reduced Detection Specificity

    Immuno-Mycologics recalls 411 Cryptococcal Antigen test kits (lots F1021035, F1021036) for reduced specificity (90% vs. 99%), which may cause false-positive results leading to unnecessary anti-fungal therapy.

    Product
    CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2301-2020·2020-06-17

    Immuno-Mycologics Recalls Histoplasma ID Antigen Due to Contamination

    Immuno-Mycologics is recalling 155 vials of Histoplasma ID Antigen because potential reagent contamination may cause false positive test results.

    Product
    Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2409-2018·2018-07-18

    Immuno-Mycologics Recalls Cryptococcal Antigen Lateral Flow Assay Strips

    Immuno-Mycologics is recalling 875 units of Cryptococcal Antigen Lateral Flow Assay strips due to a defect that may cause false negative test results.

    Product
    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cry
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1109-2017·2017-02-08

    Immuno-Mycologics Recalls Cryptococcal Antigen Lateral Flow Assay Due to False Positives

    Immuno-Mycologics is recalling 630 units of the Cryptococcal Antigen Lateral Flow Assay because specific lots have lower specificity, leading to reported false positive results.

    Product
    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2040-2016·2016-06-29

    Immuno-Mycologics Recalls Histoplasma Yeast Complement Fixation Antigen Due to Bacterial Contamination

    Immuno-Mycologics, Inc. is recalling 467 units of Histoplasma Yeast Complement Fixation Antigen Dilute (Lot 111WH3) due to bacterial contamination. The product was distributed nationwide to specific states.

    Product
    Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomyc
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Immuno-Mycologics

company in Norman, United States

Country
United States
Founded
1979

Official website

Source: Wikidata (Q30256977), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.