Events

Recall of ADVIA CENTAUR SYSTEM - 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
    99316
  • Event Risk Class
    III
  • Event Initiated Date
    2016-08-09
  • 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
    Siemens healthcare diagnostics has confirmed that the advia centaur systems myoglobin assay is not meeting the analytical sensitivity claim of < 3 ng/ml (ug/l) as specified in the advia centaur myoglobin instructions for use (ifu) for all in-date reagent lots when evaluated with calibrator u kit lots ending in 63 and 64. values up to 12 ng/ml (ug/l) were observed. siemens' investigation has identified that the calibrator u kit lots ending in 63 or 64 have drifted from the internal standardization causing a positive shift in results.

Device

ADVIA CENTAUR SYSTEM - CALIBRATORS
  • Model / Serial
    Model Catalog: 03684480 (Lot serial: CU64); Model Catalog: 03684480 (Lot serial: CU63)
  • Product Description
    ADVIA CENTAUR SYSTEM - CALIBRATORS;ADVIA CENTAUR CP SYSTEM - CALIBRATORS
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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