Events

Recall of ADVIA CENTAUR SYS-HIV AG/AB COMBO (CHIV) ASSAY (DONOR SCREEN TRANSPLANT)

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
    41053
  • Event Risk Class
    III
  • Event Initiated Date
    2013-09-17
  • 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
    The analytical sensitivity statements in the advia centaur/xp and advia centaur cp ifus were based on one lot of reagent. siemens evaluated the current p24 analytical sensitivity with multiple lots to determine if the hiv ag/ab combo (chiv) assay is meeting the ifu statements. five out of the seven lots evaluated on the advia centaur/xp and four out of seven lots evaluated on the advia centaur cp did not meet the statement in the ifu with regard to p24 analytical sensitivity. however the chiv assay is meeting the design requirements (dir target < 1.5 iu/ml dir minimum < 2.0 iu/ml) and the cts analytical sensitivity requirement of

Device

ADVIA CENTAUR SYS-HIV AG/AB COMBO (CHIV) ASSAY (DONOR SCREEN TRANSPLANT)
  • Model / Serial
    Model Catalog: 06520528 (Lot serial: 11 LOTS CONTACT MFR)
  • Product Description
    ADVIA CENTAUR SYS-HIV AG/AB COMBO (CHIV) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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