Events

Recall of Bio-Rad D-10 Rack Loader

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Biomet France SARL.

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
    19693
  • Event Initiated Date
    2016-01-22
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: Bio-Rad Laboratories Ltd, 189 Bush Road, Rosedale, AUCKLAND 0632
  • Reason
    There is a potential for a sample and result to be mismatched when running in the d-10 rack loader configuration. this means that a patient result may be assigned to an incorrect sample id., while the manufacturer investigates and prepares a permanent solution, the recommendation is that customers verify that the number of results equals the total number of samples run. if there is a discrepancy, customers should identify the rack with the missing result, rerun all samples from that rack, and check the laboratory information system (lis) results.
  • Action
    Manufacturer to issue advice regarding use

Device

Bio-Rad D-10 Rack Loader
  • Model / Serial
    Model: 220-0600, Affected: multiple items and batches
  • Manufacturer
    Biomet France SARL

Manufacturer

Biomet France SARL
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    NZMMDSA