Events

Recall of Device Recall D10 Rack Loader

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bio-Rad Laboratories, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72927
  • Event Risk Class
    Class 2
  • Event Number
    Z-0695-2016
  • Event Initiated Date
    2015-12-15
  • Event Date Posted
    2016-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142512
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Assay, glycosylated hemoglobin - Product Code LCP
  • Reason
    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.
  • Action
    Urgent Medical Device Correction letters were sent on December 2015 to all affected consignees and subsidiaries. Each subsidiary will be given a Subsidiary Medical Device Correction Notice, Customer Medical Device Correction Notice, and Return Response Form and the number of customers distributed by e-mail. Each Subsidiary much contact customers and translate the Customer Medical Device Correction Notice and Return Response Form as needed. A revised letter to subsidiaries and customers was sent on January 20, 2016.

Device

Device Recall D10 Rack Loader
  • Model / Serial
    All codes - 2006 to present
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) and the countries of Canada, Australia, Belgium, Brazil, Brunei Darussalam, China, Czech Republic, France, Germany, Greece, India, Israel, Italy, Malaysia, Maldives, New Zealand, Norway, Austria, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Thailand, and UK.
  • Product Description
    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.
  • Manufacturer
    Bio-Rad Laboratories, Inc.

Manufacturer

Bio-Rad Laboratories, Inc.
  • Manufacturer Address
    Bio-Rad Laboratories, Inc., 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Manufacturer Parent Company (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA