Immuno-Mycologics Histoplasma Antigen Test Recall: False Positive Risk
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.
Lower-risk recall
False positive results due to potential contamination of reagent.
Contact the company
What happened, in plain English
Immuno-Mycologics recalls certain Histoplasma antigen test kits because reagent contamination may cause false positive results. This could lead to incorrect health diagnoses if used without proper validation. Read more at govinfonow.com/recall/66577-immuno-mycologics-histoplasma-antigen-test-recall-false-positive-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/66577-immuno-mycologics-histoplasma-antigen-test-recall-false-positive-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2301-2020
Cite this page
“Immuno-Mycologics Histoplasma Antigen Test Recall: False Positive Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66577-immuno-mycologics-histoplasma-antigen-test-recall-false-positive-risk. Based on FDA recall #Z-2301-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2301-2020%22&limit=1).
Why it’s dangerous
The reagent in these test kits may be contaminated, causing false positive results. This means the test might incorrectly indicate infection when there is none, leading to unnecessary health concerns or treatments.
Who’s affected
Users of the specific Histoplasma Immunodiffusion antigen test kits with Lot number L106909 and UDI # (01) 00816387020391 are affected. Healthcare providers and labs using these kits may need to verify results.
How to tell if you have this one
Check for Lot number L106909 and UDI # (01) 00816387020391 on the product packaging. The affected products include Histoplasma Immunodiffusion antigen kits used in fungal antigen testing.
- Brand
Immuno-Mycologics- Product
Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens- Category
Medical device
What to do — step by step
Check Product Details
Verify the lot number and UDI on the packaging to confirm if your kit is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 12 states.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Illinois, Indiana, Michigan, Minnesota, New York, Texas, Utah, Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-2301-2020 (November 4, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2301-2020 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.