Events

Recall of ADVIA CENTAUR CP SYSTEM - FOLATE (FOL) 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
    43802
  • Event Risk Class
    III
  • Event Initiated Date
    2014-03-26
  • 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 confirmed one set of complaints with the advia centaur systems folate kit lots ending in 223. customers observed that the bio-rad liquichek and lyphochek folate serum controls may go out of range low with advia centaur systems folate kit lots ending in 223. whole blood controls with advia centaur folate reagent kit lots ending in 223 are within range and whole blood patients are consistent with previous reagent lots. in addition siemens has confirmed a second set of customer complaints regarding a shift in whole blood patients when moving from advia centaur systems folate kit lots ending in 219 to kit lots ending in 222224 225 226 and/or 227. siemens performed a whole blood normal range study that shows kit lots ending in 219 do not demonstrate a normal range pattern shown in the instructions for use (ifu). serum controls and patients show normal lot to lot variation with all in date lots of folate reagents.

Device

ADVIA CENTAUR CP SYSTEM - FOLATE (FOL) ASSAY
  • Model / Serial
    Model Catalog: 131096 (Lot serial: 226227 FOR ALL DEVICES); Model Catalog: 06891541 (Lot serial: 226227 FOR ALL DEVICES); Model Catalog: 124838 (Lot serial: 226227 FOR ALL DEVICES); Model Catalog: 06367974 (Lot serial: 226227 FOR ALL DEVICES); Model Catalog: 118551 (Lot serial: 226227 FOR ALL DEVICES); Model Catalog: 126638 (Lot serial: LOTS ENDING IN 219222224225); Model Catalog: 131096 (Lot serial: LOTS ENDING IN 219222224225); Model Catalog: 06891541 (Lot serial: LOTS ENDING IN 219222224225); Model Catalog: 124838 (Lot serial: LOTS ENDING IN 219222224225); Model Catalog: 06367974 (Lot serial: LOTS ENDING IN 219222224225); Model Catalog: 118551 (Lot serial: LOTS ENDING IN 219222224225); Model Catalog: 126638 (Lot serial: 226227 FOR ALL DEVICES)
  • Product Description
    ADVIA CENTAUR CP SYSTEM - FOLATE (FOL) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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