BD Biosciences, Systems & Reagents recalls BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.

Recall date

March 6, 2015

Source

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

Recall number

Z-1370-2015

FDA classification

Class II

Brand / firm

BD Biosciences, Systems & Reagents

Sold / distributed

Worldwide Distribution -US including TX, NJ, and OK and Internationally to Hong Kong, Japan, Singopore, and Belguim

Why it was recalled

The circuit breakers on some BD FACSCalibur instruments may have the incorrect rated amperage (20 amps instead of 2 amps) causing the circuit breaker to fail to open in an over-current situation.

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

What was recalled

BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.