Events

Recall of Calprotectin Card (20 test kit with stool vials & positive control)

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

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
    21471
  • Event Initiated Date
    2017-05-30
  • 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 Limited, 55b Richard Pearse Drive, Airport Oaks, Auckland 2022
  • Reason
    Lots cp-052 and cp-047 were evaluated using a strip reader and standard preparations of calprotectin ranging from 125 ng/ml to 4000 ng/ml. comparative results using the strip reader and visual examination showed the intensity of the reactions were stronger on lot cp-047 than lot cp-052. when the concentration of calprotectin in a stool sample is near to the test detection limit (500 ng/ml), some samples could be interpreted as negative, depending on the lot and the visual interpretation.
  • Action
    Product to be destroyed

Device

Calprotectin Card (20 test kit with stool vials & positive control)

Manufacturer

Abacus Diagnostics