Events

Recall of BC Access Ostase Calibration Kit and QC Kit

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Beckman Coulter 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
    19509
  • Event Initiated Date
    2015-11-27
  • 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: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • Reason
    The access ostase calibrator and access ostase qc lots listed above do not meet their labeled expiration dates when stored after initial use (open vial stability). when stored unopened, calibrators and quality controls are stable until the expiration date on the vials., through internal testing, beckman coulter has determined that the above lots are stable at 2 to 10°c for 58 days after initial use.
  • Action
    Product to be destroyed

Device

BC Access Ostase Calibration Kit and QC Kit
  • Model / Serial
    Model: 37305 (Calibrator), 37309 (QC), Affected: 528936 & 528938 (calibrator); 528937 & 528939 (QC)
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc