Events

Recall of IMMULITE SYSTEM - RUBELLA QUANTITATIVE IGG 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
    99753
  • Event Risk Class
    III
  • Event Initiated Date
    2016-11-15
  • 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 observed that the immulite systems rubella quantitative igg calibration verification material level cvm4 (lrubcvm4) is recovering high outside of the published instructions for use (ifu) guideline. the maximum individual replicate observed internally by siemens for lrubcvm4 using lot 0101 and 0102 was 687 iu/ml which is above the provided ifu guideline range of 352 - 528 iu/ml.

Device

IMMULITE SYSTEM - RUBELLA QUANTITATIVE IGG ASSAY
  • Model / Serial
    Model Catalog: LRUBCVM (Lot serial: 0102); Model Catalog: LRUBCVM (Lot serial: 0101)
  • Product Description
    IMMULITE SYSTEM-RUBELLA QUANTITATIVE IGG ASSAY;IMMULITE 1000 SYSTEM-RUBELLA QUANTITATIVE IGG ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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