Immuno-Mycologics product recalled over mold contamination

Recall date

May 9, 2016

Source

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

Official notice title

Immuno-Mycologics, Inc recalls Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to…

Recall number

Z-2040-2016

FDA classification

Class II

Brand / firm

Immuno-Mycologics, Inc

Sold / distributed

Nationwide Distribution to UT, MA, OH, IN, NC, NY, VA, CA, IA and KY.

Why it was recalled

The device was found to have bacterial contamination.

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

What was recalled

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