Immuno-Mycologics recalls
3 official recalls and safety alerts involving Immuno-Mycologics since 2022-02, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Immuno-Mycologics or the relevant agency.
- 2026-05-06
US
Immuno-Mycologics, Inc recalls Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium…
Neutralization Buffer may contain contaminants
FDA · DeviceImmuno-Mycologics, IncUS Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA,…Official notice →- 2025-03-26
US
Immuno-Mycologics, Inc recalls Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for…
Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
FDA · DeviceImmuno-Mycologics, IncWorldwide - US Nationwide distribution in the states of CA and OK and the…Official notice →- 2022-02-09
US
Immuno-Mycologics, Inc recalls CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003,…
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…
FDA · DeviceImmuno-Mycologics, IncUS Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA,…Official notice →