Reported Feb 9, 2022 · Terminated
CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum…
Immuno-Mycologics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Immuno-Mycologics, Inc · 2701 Corporate Centre Dr · Norman, OK · 73069-2901
Is this the product you have?
- 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
- Lot codes and dates
- F1021035 and F1021036
- Amount recalled
- 411 kits
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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