Events

Recall of Epoc BGEM Test Cart

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

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
    14449
  • Event Initiated Date
    2013-04-03
  • 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: Alere Ltd, C/- Bell Gully, Level 22, Vero Centre, 48 Shortland Street, AUCKLAND 1010
  • Reason
    Affected lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end range of glucose test sensor. specifically, in test cards aged to within 2.5 months (75 days) of their expiration date, a negative bias between of 15 - 30 % has been observed in sample with glucose levels greater than 22 mmol/l.
  • Action
    Product to be destroyed

Device

Epoc BGEM Test Cart
  • Model / Serial
    Model: Catalogue No.: CT-1004-00-00, Affected: Lot: 07-12289-00, 07-12363-00
  • Manufacturer
    Epocal Inc

Manufacturer

Epocal Inc
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    NZMMDSA