Feb

2016

Cl II EVOLIS Microplate System

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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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II EVOLIS Microplate System

Amy Sellers

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