Events

Recall of SYNCHRON SYSTEMS PHENOBARBITAL (PHE) 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
    63911
  • Event Risk Class
    II
  • Event Initiated Date
    2009-08-28
  • 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
    There is variability in results of phenobarbital (phe) reagent and drug calibrator 1. results may vary from -3% to +17% with different reagent and calibrator lot combinations when measured against the established gas chromatography flame ionization detection (gc-fid) method traceable to certified phenobarbital standards.

Device

SYNCHRON SYSTEMS PHENOBARBITAL (PHE) REAGENT
  • Model / Serial
    Model Catalog: 469785 (Lot serial: lots M810440 and earlier); Model Catalog: 469600 (Lot serial: Drug Calibrator part# 469600); Model Catalog: 469785 (Lot serial: Drug Calibrator part# 469600); Model Catalog: 469600 (Lot serial: lots M810083 and earlier); Model Catalog: 469785 (Lot serial: lots M810083 and earlier); Model Catalog: 469600 (Lot serial: Reagent part # 469785); Model Catalog: 469785 (Lot serial: Reagent part # 469785); Model Catalog: 469600 (Lot serial: lots M810440 and earlier)
  • Product Description
    PHENOBARBITAL AND DRUG CALIBRATOR 1
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.