Events

Recall of ADVIA 1200 CHEMISTRY SYSTEM - LIPASE (LIP) 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
    135859
  • Event Risk Class
    III
  • Event Initiated Date
    2015-03-26
  • 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
    Manufacturer received customer complaints for falsely elevated advia chemistry lipase results as a result of carryover from cholesterol_c dldl and triglycerides reagents. manufacturer internal investigation confirmed that current contamination avoidance settings do not prevent carryover resulting in high lipase outlier results. the results generated when this issue occurs are falsely elevated for a normal range lipase sample. customers have reported approximately a 25% positive bias while approximately a 12% positive bias was observed in-house. the issue may or may not be detected by quality controls depending on where a carryover incident occurs. if carryover occurs during qc analysis it will impact the qc result. if it does not occur during a qc analysis then the qc result will not be affected.

Device

ADVIA 1200 CHEMISTRY SYSTEM - LIPASE (LIP) ASSAY
  • Model / Serial
    Model Catalog: B01-4840-01 (Lot serial: ALL); Model Catalog: 01984894 (Lot serial: ALL)
  • Product Description
    ADVIA 1200 CHEMISTRY SYSTEM-LIPASE (LIP) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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