Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY Recalled by Immuno-Mycologics, Inc Due to The firm found immunoassay products used to detect...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Immuno-Mycologics, Inc directly.
Affected Products
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
Quantity: 411 kits
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Immuno-Mycologics, Inc
Immuno-Mycologics, Inc has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report