Events

Recall of IMMULITE 1000 SYSTEM - ANDROSTENEDIONE 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
    26181
  • Event Risk Class
    III
  • Event Initiated Date
    2013-12-24
  • 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 healthcare diagnostics has confirmed over-recovery of samples with concentrations greater than 5.5 ng/ml. siemens has determined that these lots are linear up to a concentration of 5.5 ng/ml instead of 10 ng/ml as stated in the instructions for use (ifu). quality control materials at concentrations between 5.5 and 10 ng/ml will detect this issue.

Device

IMMULITE 1000 SYSTEM - ANDROSTENEDIONE ASSAY
  • Model / Serial
    Model Catalog: LKAO1 (Lot serial: 409 and above); Model Catalog: L2KAO2 (Lot serial: 314 and above)
  • Product Description
    IMMULITE 1000 SYSTEM - ANDROSTENEDIONE ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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