Events

Recall of BEHRING NEPHELOMETER SYSTEM - N LATEX IGM

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
    71597
  • Event Risk Class
    III
  • Event Initiated Date
    2014-12-23
  • 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
    A potential for falsely low igm results obtained with serum samples when using the affected lots of n latex igm. for the assessment of intrathecal synthesis of igm with n latex igm results on cerebrospinal fluid (csf) and serum samples may be obtained from one calibration curve. if an igm quotient (igm_csf/igm_serum) is calculated using a falsely low serum result and if the result is transferred into a 'reiber diagram' this quotient will be too high and may result in an overestimation of an intrathecal igm synthesis.

Device

BEHRING NEPHELOMETER SYSTEM - N LATEX IGM
  • Model / Serial
    Model Catalog: OQAC11 (Lot serial: 44019); Model Catalog: OQAC11 (Lot serial: 44042); Model Catalog: OQAC11 (Lot serial: 44018)
  • Product Description
    BEHRING NEPHELOMETER SYSTEM - IGM NA LATEX
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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