Events

Recall of Pak Lx Assay

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

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
    21000
  • Event Initiated Date
    2017-01-10
  • 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: Diagnostic Solutions Pty Ltd, 170 Fulham Road, Fairfield, VIC 3078, AUSTRALIA
  • Reason
    The manufacturer has identified, that the conjugate diluent included in lot # 3003658 and 3004022 has an expiration date specified on its labeling which is outside that supported by the stability data. the expiration date for the conjugate diluent should be one year shorter than that provided on the labels.
  • Action
    Manufacturer to issue advice regarding use

Device

Pak Lx Assay
  • Model / Serial
    Model: , Affected: Lot # 3003658 and 3004022
  • Manufacturer
    Immucor Gamma

Manufacturer

Immucor Gamma