Events

Recall of IMMULITE SYSTEM - FOLICAL STIMULATING HORMONE (FSH) 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
    25667
  • Event Risk Class
    III
  • Event Initiated Date
    2014-10-17
  • 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
    An internal complaint identified a barcode conflict between immulite/immulite 1000 follicle- stimulating hormone (fsh) lkfs reagent wedge lots 351 and 352 where both reagent wedge lots were displayed by the software as lot '01'. this could result in the incorrect reagent wedge lot being used for a kit lot if both reagent wedges were on the instrument at the same time. an internal investigation concluded that there would be no impact to patient or quality control results if reagent wedges were mis-matched. customer complaint escalations identified "adjustment overdue" or "expired" flags when immulite /immulite 1000 fsh reagent lot 351 was stored in system history and reagent lot 352 was introduced to the system. the customer (field) confirmed "adjustment overdue" or "expired" flags could not be replicated internally. note: kit lot 351 expired august 31 2014 kit lot 352 expires october 31 2014.

Device

IMMULITE SYSTEM - FOLICAL STIMULATING HORMONE (FSH) ASSAY
  • Model / Serial
    Model Catalog: LKFS1 (Lot serial: 352); Model Catalog: LKFS1 (Lot serial: 351)
  • Product Description
    IMMULITE SYSTEM - FOLICAL STIMULATING HORMONE (FSH) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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