Events

Recall of RAPIDPOINT 405 SYSTEM - ANALYZER

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
    20391
  • Event Risk Class
    III
  • Event Initiated Date
    2014-09-03
  • 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 diagnostics has confirmed an error in the v3.9 software which may affect na+ results on your aqc cartridge (smn 10310323). level 2 & 3 na+ aqc values may be elevated but within the published target ranges. the published aqc target ranges for all other analytes are unaffected. manual quality controls are also unaffected. this software issue has been addressed with a manufacturing change to the aqc cartridges beginning with aqc cartridge lot number aqc/1774 (serial number 1403793825). aqc cartridges used on the rapidpoint 500 and rapidlab 1200 systems are not affected.

Device

RAPIDPOINT 405 SYSTEM - ANALYZER
  • Model / Serial
    Model Catalog: RAPIDPOINT 405 (Lot serial: 10896); Model Catalog: RAPIDPOINT 405 (Lot serial: 10898)
  • Product Description
    RAPIDPOINT 405 SYSTEM - ANALYZER
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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