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All product recalls associated with Immuno-Mycologics, Inc.
Total Recalls
3
Past Year
1
Class I (Serious)
0
Most Recent
Feb 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
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 patients to initiate unnecessary anti-fungal therapy. Samples with negative test results are NOT affected.
False positive results due to potential contamination of reagent.