Events

Recall of ADVIA CENTAUR XP SYSTEM-HIV1/O/2 ENHANCED(EHIV) ASSAY (DONOR SCREEN TRANSP)

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
    54745
  • Event Risk Class
    III
  • Event Initiated Date
    2011-04-28
  • 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
    Two us distributed lots of the advia centaur centaur xp and centaur cp ehiv reagents are exhibiting instability. this instability results in the positive control 3 (type o low control) recovering low and out of specification. reagent lots distributed outside the us have not demonstrated this instability however as a precautionary measure the shelf life is being reduced.

Device

ADVIA CENTAUR XP SYSTEM-HIV1/O/2 ENHANCED(EHIV) ASSAY (DONOR SCREEN TRANSP)
  • Model / Serial
    Model Catalog: 01463908 (Lot serial: >10 CONTACT MANUFACTURER)
  • Product Description
    ADVIA CENTAUR HIV 1/O/2 ENHANCED (EHIV) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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