FDA-Device2016-02-24Class II
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.
Bio-Rad Laboratories, Inc.
Hazard
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.
Sold states
US Nationwide Distribution including Puerto Rico.
Affected count
278 units
Manufactured in
6565 185th Ave NE, Redmond, WA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0807-2016Don't want to check this manually?
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