Events

Recall of RAPIDPOINT 500 SYSTEM - LACTATE MEASUREMENT CARTRIDGES

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
    57900
  • Event Risk Class
    III
  • Event Initiated Date
    2014-05-30
  • 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 received several reports from customers of one or more electrolyte parameters (e.G. na+ ca++ k+ cl-) reporting a "-----?" error code when aqc qc or cvm is run on the rapidpoint 500 blood gas analyzer. when exhibited the tissue is usually seen during level 1 qc/aqc level 1 cvm and sometimes level 2 cvm testing. this issue has also been observed on a small number of patient samples. this issue impacts only rapidpoint 500 measurement cartridges p/ns 10491447 10491448 10491449 and 10844813. siemens has observed this issue with rapidpoint 500 measurement cartridges with serial numbers up to 2412705915 however not all these cartridges will exhibit this behavior. the issue does not impact rapidpoint 400 or rapidpoint 405 measurement cartridges.

Device

RAPIDPOINT 500 SYSTEM - LACTATE MEASUREMENT CARTRIDGES
  • Model / Serial
    Model Catalog: 10491447 (Lot serial: 2334500011 THROUGH 2412705915); Model Catalog: 10491448 (Lot serial: 2334500011 THROUGH 2412705915); Model Catalog: 10491449 (Lot serial: 2334500011 THROUGH 2412705915); Model Catalog: 10844813 (Lot serial: 2334500011 THROUGH 2412705915)
  • Product Description
    RAPIDPOINT 500 SYSTEM - LACTATE MEASUREMENT CARTRIDGES
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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