Events

Recall of SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT

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
    103652
  • Event Risk Class
    II
  • Event Initiated Date
    2017-04-04
  • 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 the following drugs as potential sources of interference: metamizole (dipyrone) - analgesic/antispasmodic/antipyretic (note: no longer approved for sale in certain geographies including the us and canada) may generate false low cholesterol enzymatic creatinine hdl cholesterol lactate triglycerides and uric acid results. sulfasalazine - anti-inflammatory may generate false high salicylate results. sulfapyridine - sulfonamide antibiotic may generate false low salicylate results.

Device

SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
  • Model / Serial
    Model Catalog: 467825 (Lot serial: ALL); Model Catalog: A95550 (Lot serial: ALL); Model Catalog: 378194 (Lot serial: ALL); Model Catalog: A60298 (Lot serial: ALL); Model Catalog: A15625 (Lot serial: ALL); Model Catalog: 442785 (Lot serial: ALL); Model Catalog: 445850 (Lot serial: ALL)
  • Product Description
    CHOLESTEROL REAGENT (CHOL);LACTATE REAGENT (LACT);SALICYLATE REAGENT (SALY);ENZYMATIC CREATININE REAGENT (CR-E);HDL CHOLESTEROL REAGENT (HDL);URIC ACID REAGENT (URIC);TRIGLYCERIDES REAGENT (TG AND TG-B)
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.