Events

Recall of ADVIA CENTAUR SYSTEM - BR (27.29) 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
    52957
  • Event Risk Class
    III
  • Event Initiated Date
    2017-03-09
  • 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
    Potential for the advia centaur syphilis assay to interfere with the br (ca 27.29) assay on the advia centaur systems. this interference only occurs when the syphilis assay immediately precedes the br assay on the advia centaur advia centaur xp or advia centaur xpt systems. the advia centaur cp system is not impacted. the issue affects all current and future lots of advia centaur systems br reagents until a solution is implemented.

Device

ADVIA CENTAUR SYSTEM - BR (27.29) ASSAY
  • Model / Serial
    Model Catalog: 03896216 (Lot serial: 83525216 89376220); Model Catalog: 03896216 (Lot serial: 20739217 41765219 1472217); Model Catalog: 02419937 (Lot serial: 4740821967429220 73596216); Model Catalog: 03896216 (Lot serial: 4740821967429220 73596216); Model Catalog: 02419937 (Lot serial: 83525216 89376220); Model Catalog: 02419937 (Lot serial: 20739217 41765219 1472217)
  • Product Description
    ADVIA Centaur / XP / XPT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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