Events

Recall of BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM - CREATININE (ENZYMATIC)

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
    18909
  • Event Risk Class
    II
  • Event Initiated Date
    2014-12-05
  • 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
    N-acetyl cysteine (nac) when administered in therapeutic concentrations in excess of 500 mg/l (for the treatment of acetaminophen overdose) has been recently determined to interfere with assays for the following analytes: enzymatic creatinine osr6x204 cholesterol osr6x16 uric acid osr6x98 lactate osr6x93 and lipase osr6x30. only these assays are affected. nac is an anti-oxidant and can interfere with assays employing trinder chemical pathways i.E. where hydrogen peroxide (h2o2) is formed and subsequenly reacted with aminoantipyrine and an indicator in the presence of a peroxidase as a catalyst. nac interference has been demonstrated to occur to varying degrees depending on the analyte and therefore not all assays employing trinder chemical pathways are affected. nac interference may lead to falsely low results.

Device

BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM - CREATININE (ENZYMATIC)
  • Model / Serial
    Model Catalog: OSR61204 (Lot serial: ALL LOTS); Model Catalog: OSR6616 (Lot serial: ALL LOTS); Model Catalog: OSR6116 (Lot serial: ALL LOTS); Model Catalog: OSR6216 (Lot serial: ALL LOTS); Model Catalog: OSR6516 (Lot serial: ALL LOTS); Model Catalog: OSR6698 (Lot serial: ALL LOTS); Model Catalog: OSR6298 (Lot serial: ALL LOTS); Model Catalog: OSR6130 (Lot serial: ALL LOTS); Model Catalog: OSR6198 (Lot serial: ALL LOTS); Model Catalog: OSR6098 (Lot serial: ALL LOTS); Model Catalog: OSR6230 (Lot serial: ALL LOTS); Model Catalog: OSR6193 (Lot serial: ALL LOTS)
  • Product Description
    BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM - ENZYMATIC CREATININE
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.