Immuno-Mycologics, Inc recall records

2 reported ongoing

3 records in this archive. Latest source date Mar 26, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

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

Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of CA and OK and the countries of Peru France, Austria, Venezuela.

Official source for Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Con...
FDA device enforcement

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

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...

Class IIReported terminated

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.

Official source for CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococc...

Reasons in these listed records

  • Neutralization Buffer may contain contaminants
  • Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
  • 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 pati...

These examples come from this result page and are not a ranking of every recall reason.

Checking Immuno-Mycologics, Inc

Is there a recall on immuno-mycologics, inc right now?

This archive contains 3 records, including 2 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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