Beckman Coulter Inc. recalls Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product Usage: The Access 2 and UniCel DxI Access Im…

Recall date

March 7, 2017

Source

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

Recall number

Z-1710-2017

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

Affected geographies: Algeria, Austria, Australia, Bangladesh, Bulgaria, Brazil, Canada, China, Costa Rica, Cyprus, Colombia, Czech Republic, El Salvador, France, Germany, Ghana, Greece, Guatemala, India, Indonesia, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Lithuania, Malawi, Mexico, Morocc…

Why it was recalled

Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the instrument is running. The position errors cause the instrument to stop running and cancel tests that are in process.

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

What was recalled

Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.