Company: Bio-Rad Laboratories, Inc.
Date of Enforcement Report 2/24/2016
Class lI:

PRODUCT

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. Recall Number Z-0807-2016

REASON
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.

RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Inc., Redmond, WA on 12/22/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
278 units

DISTRIBUTION
US Nationwide and Puerto Rico

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