Events

Recall of Phadia ImmunoCAP Allergen c5

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

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
    22421
  • Event Initiated Date
    2018-01-05
  • 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: Abacus ALS Limited, 55b Richard Pearse Drive, Airport Oaks, Auckland 2022
  • Reason
    An issue has been found with the stability of immunocap allergen c5, ampicilloyl and immunocap allergen c6, amoxicilloyl. an internal monitoring real time stability study determined that the stability specifications were not met. the products have a nominal 12 months shelf life stated on the label.
  • Action
    Product to be destroyed

Device

Phadia ImmunoCAP Allergen c5
  • Model / Serial
    Model: , Affected: Phadia ImmunoCAP™ Allergen c5, Ampicilloyl and ImmunoCAP™ Allergen c6, Amoxicilloyl, All lot numbers
  • Manufacturer
    Phadia AB

Manufacturer

Phadia AB