bioMerieux, Inc. recalls VIDAS Testosterone, Ref 30418

Recall date

May 15, 2017

Source

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

Recall number

Z-2339-2017

FDA classification

Class II

Brand / firm

bioMerieux, Inc.

Sold / distributed

AR, CA, CO, GA, IL, IA, MI, MN, MT, NY, OK, TN, TX, WY, Columbia, Costa Rica, El Salvador, France, Hong Kong, Jordan, Nicaragua, Russian Fed., Sri Lanka, Sweden, Ukraine

Why it was recalled

Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone.

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

What was recalled

VIDAS Testosterone, Ref 30418