Events

Recall of ADVIA CENTAUR SYSTEM - VITAMIN D TOTAL (VITD) REAGENTS

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
    43716
  • Event Risk Class
    III
  • Event Initiated Date
    2016-10-05
  • 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 a change in bias between serum and plasma specimen tubes with the advia centaur vitamin d assay as compared to instructions for use (ifu). newly evaluated data demonstrate a deming regression slope between 0.93 and 0.95 for plasma samples as compared to serum samples whereas the specimen collection comparison data provided in the ifu indicates a linear regression slope of up to 1.09.

Device

ADVIA CENTAUR SYSTEM - VITAMIN D TOTAL (VITD) REAGENTS
  • Model / Serial
    Model Catalog: 10699201 (Lot serial: ALL IN DATE AND FUTURE LOTS); Model Catalog: 10699533 (Lot serial: ALL IN DATE AND FUTURE LOTS)
  • Product Description
    ADVIA CENTAUR SYSTEM-VITAMIN D TOTAL (VITD) REAGENTS
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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