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Immuno-Mycologics, Inc recalls Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
Recalled February 8, 2017 · FDA recall Z-1109-2017 · Immuno-Mycologics
Hazard
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. · FDA Class II
Units
630 units
Sold at
Nationwide throughout the US
Description
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.
Product
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
Manufacturer(s)
Immuno-Mycologics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →