Events

Recall of ADVIA CENTAUR CP SYSTEM - FOLATE (FOL) ASSAY

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
    22793
  • Event Risk Class
    III
  • Event Initiated Date
    2013-07-29
  • 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 has confirmed that a portion of folate readypacks in kit lots ending in 218 are exhibiting calibration failures and/or significant negative shifts in quality control (qc) and patient results. if the calibration and qc on a readypack are valid results generated with this readypack are not affected. however due to the sporadic nature of the issue successful calibration and qc on one readypack may not reflect acceptable performance of other readypacks in the lot.

Device

ADVIA CENTAUR CP SYSTEM - FOLATE (FOL) ASSAY
  • Model / Serial
    Model Catalog: 124838 (Lot serial: 22288218); Model Catalog: 118551 (Lot serial: 22288218); Model Catalog: 124838 (Lot serial: ); Model Catalog: 118551 (Lot serial: ); Model Catalog: 131096 (Lot serial: ); Model Catalog: 126638 (Lot serial: ); Model Catalog: 131096 (Lot serial: FOR ALL); Model Catalog: 126638 (Lot serial: FOR ALL); Model Catalog: 124838 (Lot serial: FOR ALL); Model Catalog: 118551 (Lot serial: FOR ALL); Model Catalog: 131096 (Lot serial: 22299218); Model Catalog: 126638 (Lot serial: 22299218); Model Catalog: 124838 (Lot serial: 22299218); Model Catalog: 118551 (Lot serial: 22299218); Model Catalog: 131096 (Lot serial: 22298218); Model Catalog: 126638 (Lot serial: 22298218); Model Catalog: 124838 (Lot serial: 22298218); Model Catalog: 118551 (Lot serial: 22298218); Model Catalog: 131096 (Lot serial: 22535218); Model Catalog: 126638 (Lot serial: 22535218); Model Catalog: 124838 (Lot serial: 22535218); Model Catalog: 118551 (Lot serial: 22535218); Model Catalog: 131096 (Lot serial: 22297218); M
  • Product Description
    ADVIA CENTAUR CP SYSTEM-FOLATE (FOL) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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