Recall Register

Immuno-Mycologics, Inc: FDA recalls

FDA enforcement reports name Immuno-Mycologics, Inc as the recalling firm in 7 events. The events have 7 product records. The recalls started from 2016 to 2026. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

7 events, newest first.

FDA enforcement events of Immuno-Mycologics, Inc
InitiatedProduct (first record)TypeClassRecordsStatus
26 Mar 2026Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosisDeviceClass II1Ongoing
10 Feb 2025Candida 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, CEDeviceClass II1Ongoing
3 Jan 2022CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919DeviceClass II1Terminated
4 Nov 2019Histoplasma 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 AntigenDeviceClass II1Terminated
30 Mar 2018Cryptococcal 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 (Cryptococcus neoformans and Cryptococcus…DeviceClass II1Terminated
27 Dec 2016Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003DeviceClass II1Terminated
9 May 2016Histoplasma 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, blastomycosis, coccidioidomycosis, and…DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Immuno-Mycologics, Inc: events for each product type
TypeEvents
Device7
Immuno-Mycologics, Inc: events in each class
ClassEvents
Class II7
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
2

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Immuno-Mycologics, Inc, by the year that the recall started. The largest year is 2016, with 2 events.

Official channels

Cite this page

Recall Register. Immuno-Mycologics, Inc: FDA recalls. https://recallregister.com/firm/immuno-mycologics-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
OK

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Immuno-Mycologics, Inc have?
Class II: 7 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Immuno-Mycologics, Inc?
FDA event 98702, which the firm started on 26 Mar 2026. The first product in the record is: Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
How many FDA recalls of Immuno-Mycologics, Inc have the status Ongoing?
2 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.