Cl II Bio-Rad D-10 Rack Loader

Company: Bio-Rad Laboratories Inc.
Date of Enforcement Report 2/3/2016
Class lI:


D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection, and analysis.
Recall Number Z-0695-2016

On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running in D10 Rack Loader configuration..

Bio-Rad Laboratories, Inc., Hercules, CA on 12/15/2015. Voluntary: Firm Initiated recall is ongoing.

165 in US, 200 Internationally

Nationwide and Internationally.


About the author

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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