Events

Recall of ACCESS SYSTEM - OSTASE ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER CANADA L.P..

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
    134801
  • Event Risk Class
    III
  • Event Initiated Date
    2015-11-20
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Beckman coulter has determined through internal testing that access ostase calibrator lots 528936 528938 and access ostase qc lots 528937 528939 do not meet their labelled expiration dates when stored after initial use (open vial stability). beckman coulter has determined that the above lots are stable at 2 to 10 degrees celcius for 58 days after initial use (i.E. after the vials are first opened). when stored unopened calibrators and quality controls are stable until the expiration date on the vials.

Device

ACCESS SYSTEM - OSTASE ASSAY
  • Model / Serial
    Model Catalog: 37305 (Lot serial: 528939); Model Catalog: 37309 (Lot serial: 528937); Model Catalog: 37305 (Lot serial: 528936); Model Catalog: 37309 (Lot serial: 528938); Model Catalog: 37305 (Lot serial: 528938); Model Catalog: 37309 (Lot serial: 528936); Model Catalog: 37309 (Lot serial: 528939); Model Catalog: 37305 (Lot serial: 528937)
  • Product Description
    ACCESS SYSTEM - OSTASE ASSAY
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.