Events

Recall of Immucor Capture-R Ready Indicator cells

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
    13422
  • Event Initiated Date
    2012-08-30
  • 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: Abacus ALS, 12 Mowbray Terrace, East Brisbane, QLD 4169, AUSTRALIA
  • Reason
    Post-release testing has demonstrated this lot may result in higher rates for equivocal and unexpected positive reactions compared to other in-date or previously released lots. there may be a moderate risk associated with false positive results with the weak d assay.
  • Action
    Product to be destroyed

Device

Immucor Capture-R Ready Indicator cells
  • Model / Serial
    Model: 006427 and 0006428, Affected: 221861
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479