Immuno-Mycologics, Inc recalls Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003

Recall date

December 27, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1109-2017

FDA classification

Class II

Brand / firm

Immuno-Mycologics, Inc

Sold / distributed

Nationwide throughout the US

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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