Beckman Coulter Inc. recalls Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vitro diagnostic device used for the quantitativ…

Recall date

November 6, 2017

Source

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

Recall number

Z-0309-2018

FDA classification

Class III

Brand / firm

Beckman Coulter Inc.

Sold / distributed

Worldwide Distribution -- US, Argentina, Canada, Chile, China, Columbia, Costa Rica, France, Georgia, Germany, Ghana, Greece, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Morocco, Myanmar, Nepal, Philippines, Poland, Russia, Rwanda, Saudi Arabia, Slovakia, South Africa, South Korea, Thailand…

Why it was recalled

Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.