Immuno-Mycologics, Inc recalls
Every recall we track for Immuno-Mycologics, Inc — 5 in all, from 2018–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
5 recalls since 2017.
All FDA recall records for Immuno-Mycologics, Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 1 | 0 | 1 |
| 2019 | 0 | 0 | 1 | 0 | 1 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 1 | 0 | 1 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 1 | 0 | 1 |
What to do if you have a recalled Immuno-Mycologics, Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Immuno-Mycologics, Inc recalls
5 shown- Lower riskMedical device
Immuno-Mycologics, Inc recalls Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens
Immuno-Mycologics recalls bulk neutralization buffer for clinical specimen processing due to potential contaminants. Affected units include specific lot numbers for Mycobacterium diagnosis tests.
Immuno-MycologicsMar 26, 2026 - Lower riskMedical device
Immuno-Mycologics, Inc recalls Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, &
Immuno-Mycolog: Candida ID Antigen products may give false negative results. Recalled due to reduced sensitivity. Contact for replacement.
Immuno-MycologicsFeb 10, 2025 - Lower riskMedical device
Immuno-Mycologics, Inc recalls CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum
Immuno-Mycologics recalls IMMY Cryptococcal Antigen Lateral Flow Assay due to reduced specificity causing false positives. Affected tests may lead to unnecessary anti-fungal treatment. No action needed for negative results.
Immuno-MycologicsJan 3, 2022 - Lower riskMedical device
Immuno-Mycologics, Inc recalls Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens,
Immuno-Mycologics recalls specific Histoplasma Immunodiffusion antigen products due to potential false positive results from reagent contamination. Affected items include Lot L106909 with UDI # (01) 008163870:20391. No action needed if not affected.
Immuno-MycologicsNov 4, 2019 - Lower riskMedical device
Immuno-Mycologics, Inc recalls Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an
Immuno-Mycologics recalls Cryptococcal Antigen Lateral Flow Assay (CrAg LFA) Model CR2003 due to potential false negative results in cryptococcosis testing. Affected lots L102802 and L103012.
Immuno-MycologicsMar 30, 2018
Immuno-Mycologics, Inc recall questions
How many recalls has Immuno-Mycologics, Inc had?
5 recalls from Immuno-Mycologics, Inc are on record with U.S. safety agencies, from 2018–2026.
What is the most recent Immuno-Mycologics, Inc recall?
Immuno-Mycologics, Inc recalls Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens, dated Mar 26, 2026. Every Immuno-Mycologics, Inc recall is listed on this page, newest first.
What should I do if I have a recalled Immuno-Mycologics, Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Immuno-Mycologics, Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.