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Immuno-Mycologics, Inc recalls Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to
Recalled June 29, 2016 · FDA recall Z-2040-2016 · Immuno-Mycologics
Hazard
The device was found to have bacterial contamination. · FDA Class II
Units
467 units
Sold at
Nationwide Distribution to UT, MA, OH, IN, NC, NY, VA, CA, IA and KY.
Description
The device was found to have bacterial contamination.
Product
Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosis
Manufacturer(s)
Immuno-Mycologics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →