Events

Recall of RAPIDQC COMPLETE LEVEL 2

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
    55337
  • Event Risk Class
    III
  • Event Initiated Date
    2014-07-03
  • 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 diagnositcs has confirmed an error in the expected values chart pertaining to the level 2 ph control range for all siemens blood gas instruments namely the rapidpoint 400/405/500 systems rapidlab 1200 series systems rapidlab 248/348/348ex systems rapidlab 800 series systems and the rapidpoint 340/350 systems. due to this error the recovery of ph for rapidqc complete level 2 lot # 362303 is elevated on all siemens blood gas systems. it is also possible that some instruments may on occasion recover ph out of range high. however the published target ranges for all other analytes are unaffected.

Device

RAPIDQC COMPLETE LEVEL 2
  • Model / Serial
    Model Catalog: 10309926 (Lot serial: 362303)
  • Product Description
    RAPIDQC COMPLETE LEVEL 2
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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