Events

Recall of ADVIA CHEMISTRY SYSTEM - CHEMISTRY 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
    41193
  • Event Risk Class
    III
  • Event Initiated Date
    2013-09-27
  • 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
    Quality control (qc) is shifting higher impacting direct bilirubin (dbil_2) with siemens chemistry calibrator lots 090445b and 090445c from previous lots 090445 and 090445a. observed qc shifts are ~7-9% higher with calibrator lots 090445b and 090445c. an urgent field safety notice has been issued by the manufacturer to provide affected customers with reassigned system specific values for the dbil_2 ssvs for chemistry calibrator lot numbers 090445b and 090445c. manufacturer has determined that the dbil_2 ssvs currently assigned to these lots may cause an average shift of +7-9% in quality control and sample recovery at a level of 3 mg/dl. the urgent field safety notice provides reassigned values for the dbil_2 ssvs for chemistry calibrator lot numbers 090445b and 090445c.

Device

ADVIA CHEMISTRY SYSTEM - CHEMISTRY CALIBRATORS
  • Model / Serial
    Model Catalog: T03-1291-62 (Lot serial: 090445C); Model Catalog: 09784096 (Lot serial: 090445C); Model Catalog: 10312279 (Lot serial: 090445C); Model Catalog: T03-1291-62 (Lot serial: 090445B); Model Catalog: 09784096 (Lot serial: 090445B); Model Catalog: 10312279 (Lot serial: 090445B)
  • Product Description
    ADVIA CHEMISTRY SYSTEM - CHEMISTRY CALIBRATORS
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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