Events

Recall of ADVIA CENTAUR CP SYSTEM - INSTRUMENT CLASS IV

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
    16141
  • Event Risk Class
    III
  • Event Initiated Date
    2016-04-04
  • 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
    There are two inaccuracies that exist in the advia centaur cp operator's guide appendix d pre-set tube types. the first refers to the sample volume supported by the system when using the ezee-nest cup to process samples. the operator's guide states that sample volumes greater than 50 ul can be used however volumes greater than 150 ul cannot be used when using an ezee-nest insert cup. the second refers to the use of the universal cup adaptor with an ezee-nest insert cup in 65-mm sample racks. siemens has determined that the height of an ezee-nest insert cup with universal cup adaptor fitted on a 65-mm sample rack will not fit into the sample compartment. no samples will be processed.

Device

ADVIA CENTAUR CP SYSTEM - INSTRUMENT CLASS IV
  • Model / Serial
    Model Catalog: 086-A002-01 (Lot serial: ALL); Model Catalog: 09662772 (Lot serial: ALL)
  • Product Description
    ADVIA CENTAUR CP SYSTEM-INSTRUMENT CLASS IV;ADVIA CENTAUR CP SYSTEM-INSTRUMENT CLASS III;ADVIA CENTAUR CP SYSTEM-INSTRUMENT CLASS II
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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