Class I - Dangerous
Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
Immuno-Mycologics
6 recalls • • Categories: Diagnostic Equipment, Infusion Pumps, Other Medical Devices
Class I - Dangerous
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.
Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results
Class I - Dangerous
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.
The device was found to have bacterial contamination.