Events

Recall of DIMENSION CLINICAL CHEMISTRY SYSTEM - PHENYTON

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE LIMITED.

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
    102263
  • Event Risk Class
    II
  • Event Initiated Date
    2014-09-22
  • 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
    Internal testing has confirmed a low absorbance with ptn flex lot fa5154 resulting in the potential for a positive or negative bias and imprecision across the ptn assay range. internal studies demonstrate the bias is variable across the assay range from 9-38%. the highest degree of bias is observed below the therapeutic range of 10-20 ug/ml (39.6-79.2 umol/l). the reagent blank absorbance for ptn lot fa5154 may also generate abnormal reaction flags. the issue may be detected by qc or failed calibrations. if undetected by qc it may manifest as inaccuracy or imprecision with patient samples.

Device

DIMENSION CLINICAL CHEMISTRY SYSTEM - PHENYTON
  • Model / Serial
    Model Catalog: DF64 (Lot serial: FA5154); Model Catalog: 10444940 (Lot serial: FA5154)
  • Product Description
    DIMENSION CLINICAL CHEMISTRY SYSTEM-PHENYTOIN
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC