Hardy Diagnostics recalls Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box Product Usage: Brain Hear…

Recall date

June 26, 2015

Source

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

Recall number

Z-2274-2015

FDA classification

Class II

Brand / firm

Hardy Diagnostics

Sold / distributed

U.S. Nationwide Distribution and the country of: Canada

Why it was recalled

Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance.

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

What was recalled

Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box Product Usage: Brain Heart Infusion Broth with Ciprofloxacin, 1ug is for use as pre-enrichment broth for the cultivation of ciprofloxacin-resistant organisms from clinical samples.