Norman, OK, United States
Immuno-Mycologics, Inc recalls
5 recalls recorded since 2018, most recently on 26 March 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)2
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 26 March 2026
- Reason
- Neutralization Buffer may contain contaminants
- Distribution
- US Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1984-2026
- Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
Ongoing Class II Medical devices
- Recall started
- 10 February 2025
- Reason
- Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA and OK and the countries of Peru France, Austria, Venezuela.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1389-2025
- 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
Terminated Class II Medical devices
- Recall started
- 3 January 2022
- Terminated
- 15 May 2024
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0545-2022
- 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
Terminated Class II Medical devices
- Recall started
- 4 November 2019
- Terminated
- 27 May 2022
- Reason
- False positive results due to potential contamination of reagent.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, FL, IL, IN, MI, MN, NY,TX, UT, VA, WI and the countries of France, Spain, Hong Kong, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2301-2020
- 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 A
Terminated Class II Medical devices
- Recall started
- 30 March 2018
- Terminated
- 21 May 2020
- Reason
- Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results
- Distribution
- On March 30, 2018, IMMY began issuing URGENT MEDICAL DEVICE RECALL notices to customers via email. Customers were advised on how to recognize that the device has failed. The following are Actions to be taken by the customer/user: " You may continue using the affected lots. Any testing perform
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2409-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.