Events

Recall of ADVIA CHEMISTRY SYSTEM - TDM CALIBRATORS

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
    91455
  • Event Risk Class
    III
  • Event Initiated Date
    2015-05-08
  • 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
    Customer complaints indicate intermittent calibration failures due to max fit deviations when using digoxin reagents (smn 10327549) with therapeutic drug monitoring (tdm) calibrator lot 300645. in most cases customers were able to recalibrate the assay after repeat calibrations. if digoxin calibration does not pass on the advia chemistry system patient samples cannot be run or reported. there are only two current lots of tdm calibrators and both were evaluated for max fit deviations. this confirmed failure when using tdm calibrator lot 300645. the new tdm calibrator lot 324889 did not have any failed calibrations due to max fit deviations. the tdm calibrator is used only for the digoxin assay.

Device

ADVIA CHEMISTRY SYSTEM - TDM CALIBRATORS
  • Model / Serial
    Model Catalog: 01661874 (Lot serial: 300645)
  • Product Description
    Advia Chemistry System-TDAM Calibrators
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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