Events

Recall of Bio-Rad D-10 Hemoglobin Testing System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by manufacturer #1479.

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
    16350
  • Event Initiated Date
    2014-03-05
  • 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
    On a rare occasion the d-10 software might generate an extra result by duplicating the result from the previous sample and the sample id/injection # from the next sample., the duplicate is readily detectable when sorting the daily summary by the injection # and reviewing for duplication of the same sample id number. we recommend carefully reviewing the daily summary and/or the printed chromatograms for duplicate injection numbers or sample ids. such duplication could potentially lead to discrepant sample results, which should not be reported.
  • Action
    Manufacturer to issue advice regarding use

Device

Bio-Rad D-10 Hemoglobin Testing System
  • Model / Serial
    Model: Catalogue Number: 220-0220, Affected:
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479