Integrated Science Systems Inc recalls Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is use…

Recall date

February 19, 2016

Source

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

Recall number

Z-1911-2016

FDA classification

Class II

Brand / firm

Integrated Science Systems Inc

Sold / distributed

Nationwide distribution to CA only.

Why it was recalled

Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures.

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

What was recalled

Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture