Lower risk Medical device recall · FDA · Published January 3, 2022

Immuno-Mycologics IMMY Cryptococcal Antigen Test Recall: False Positives Risk

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0545-2022Medical device Immuno-Mycologics ›

Lower-risk recall

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.

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Contact the company

Recalling firmImmuno-Mycologics, Inc2701 Corporate Centre Dr · Norman, OK 73069-2901

✎ GovInfoNow plain-language explainer

Immuno-Mycologics recalls its IMMY Cryptococcal Antigen Lateral Flow Assay tests because they now have lower specificity (90% vs 99% before), which can cause false positive results. This might lead to unnecessary anti-fungal treatment for some patients. Negative test results are not affected by this issue. Read more at govinfonow.com/recall/61322-immuno-mycologics-immy-cryptococcal-antigen-test-recall-false-positives-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/61322-immuno-mycologics-immy-cryptococcal-antigen-test-recall-false-positives-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0545-2022

Cite this page

“Immuno-Mycologics IMMY Cryptococcal Antigen Test Recall: False Positives Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61322-immuno-mycologics-immy-cryptococcal-antigen-test-recall-false-positives-risk. Based on FDA recall #Z-0545-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0545-2022%22&limit=1).

The FDA announced on Jan. 3, 2022, that Immuno-Mycologics, Inc. is recalling Cryptococcal Antigen Lateral Flow Assay kits due to reduced specificity. The agency said the recall was voluntary and has since been terminated.

How to tell if you have it

Brand: Immuno-Mycologics
Product: CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum
UPC: 00816387020919

The hazard

The firm found the immunoassay products to have reduced specificity, dropping from 99% to 90%. 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.

Context

GovInfoNow's records show Immuno-Mycologics, Inc. has 4 other recalls on record since 2018-03-30. Other recent recalls of similar products include Immuno-Mycologics Immy Neutralization Buffer Recall (2026-03-26), Immuno-Mycologics Candida ID Antigen Recall (2025-02-10), and Immuno-Mycologics Histoplasma Antigen Test Recall (2019-11-04). Other recent recalls of similar products include Meridian Bioscience Revogene C. difficile Test Recall (2025-12-05), GET TESTED Mycotoxin Panel Test Recall (2025-11-03), and GET TESTED Mycoplasma Test Recall (2025-11-03).

How to tell if you have this one

The affected product is the IMMY Cryptococcal Antigen Lateral Flow Assay, with reference numbers CR2003, IVD, UDI: (01)00816387020919; F1021035 and F1021036. It was sold for detecting cryptococcal antigen in serum and cerebrospinal fluid.

Brand
Immuno-Mycologics
Product
CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Test Results
If you have a positive test result, consult your healthcare provider to determine if additional testing is needed.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 34 states.

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

Jan 3, 2022Firm started the recall
Jan 31, 2022FDA classified it Class II
Feb 9, 2022Published in FDA’s Enforcement Report
May 15, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61322-immuno-mycologics-immy-cryptococcal-antigen-test-recall-false-positives-risk">Immuno-Mycologics IMMY Cryptococcal Antigen Test Recall: False Positives Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0545-2022 (January 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0545-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.