Events

Recall of BECKMAN COULTER AU2700 IMMUNOCHEM SYS - URIC ACID(NEW FORMULATION)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
    19493
  • Event Risk Class
    I
  • Event Initiated Date
    2016-04-12
  • 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 identified that there is a possibility that drug interferences from administration of metamizole (dipyrone) to patients may generate false low results with the assays which are the subject of this recall. the issue was discovered on 23rd feb 2016 internally by beckman coulter.

Device

BECKMAN COULTER AU2700 IMMUNOCHEM SYS - URIC ACID(NEW FORMULATION)ASSAY
  • Model / Serial
    Model Catalog: OSR6298 (Lot serial: ALL LOTS); Model Catalog: OSR6198 (Lot serial: ALL LOTS); Model Catalog: OSR6098 (Lot serial: ALL LOTS); Model Catalog: OSR6616 (Lot serial: ALL LOTS); Model Catalog: OSR6516 (Lot serial: ALL LOTS); Model Catalog: OSR6216 (Lot serial: ALL LOTS); Model Catalog: OSR6116 (Lot serial: ALL LOTS); Model Catalog: OSR6193 (Lot serial: ALL LOTS); Model Catalog: OSR60118 (Lot serial: ALL LOTS); Model Catalog: OSR61118 (Lot serial: ALL LOTS); Model Catalog: OSR66118 (Lot serial: ALL LOTS); Model Catalog: OSR61204 (Lot serial: ALL LOTS); Model Catalog: OSR6130 (Lot serial: ALL LOTS); Model Catalog: OSR6230 (Lot serial: ALL LOTS)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Product Description
    Uric Acid OSR6x98;Cholesterol OSR6x16;Lactate OSR6x93;Triglyceride OSR6x118;Enzymatic Creatinine OSR6x204;Lipase OSR6x30
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.