Bio-Rad Laboratories, Inc. recalls EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic Prod…

Recall date

December 22, 2015

Source

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

Recall number

Z-0807-2016

FDA classification

Class II

Brand / firm

Bio-Rad Laboratories, Inc.

Sold / distributed

US Nationwide Distribution including Puerto Rico.

Why it was recalled

The error "Washer Reagent Clean Fluid" level low alarmed, which prompted the customer to open the system drawer. When the system drawer was opened the customer noted the plate transport was still running and as a consequence the plate was pushed off the plate transporter.

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

What was recalled

EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic Product Usage: EVOLIS Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays.