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.
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.
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.
The test has reduced specificity, meaning it now gives positive results for some samples that should be negative. This can cause unnecessary anti-fungal treatment for patients who don't actually have the infection. Negative test results are unaffected.
Patients using the IMMY Cryptococcal Antigen Lateral Flow Assay for testing may be affected if they get a false positive result. Those with negative results are not at risk from this issue.
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.
If you have a positive test result, consult your healthcare provider to determine if additional testing is needed.
No, negative test results are not affected by this issue and do not need to be discarded.
The test has reduced specificity, meaning it now gives positive results for some samples that should be negative, which could lead to unnecessary anti-fungal treatment.
The recalled product is the IMMY Cryptococcal Antigen Lateral Flow Assay with reference numbers CR2003, IVD, UDI: (01)00816387020919; F1021035 and F1021036.
We’ve drafted a message you can send Immuno-Mycologics to request your refund or repair — edit it as you like.
Subject: Recall Z-0545-2022 — Immuno-Mycologics Immuno-Mycologics Hello, I own a Immuno-Mycologics that is covered by recall Z-0545-2022 from Immuno-Mycologics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
