Antisera, Latex Agglutination, Cryptococcus Neoformans

Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003

The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who reported false positive results.

CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)008163

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.

Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003

Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results