Events

Recall of Siemens RAPIDPoint 400 Measurement Cartridge

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics Inc.

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
    75108
  • Event Risk Class
    Class 3
  • Event Number
    Z-2912-2016
  • Event Initiated Date
    2016-09-02
  • Event Date Posted
    2016-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149371
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Coulometric, chloride - Product Code JFS
  • Reason
    Error in the value assignment for the chloride calibrators in the rapidpoint 400 and rapidpoint 405 measurement cartridge.
  • Action
    Siemens Healthcare issued An Urgent Field Safety Notice via e-mail to affected Siemens Healthcare Diagnostics Regional offices on September 2, 2016 both in the United States and outside of the United States, for communication with affected customers e: the bias of the chloride values. US accounts sent hard copy via Federal Express and requested to: Complete and return the Field Correction Effectiveness Check form attached to this letter within 7 days. Review this letter with your Medical Director. Questions:Contact your Siemens Customer Care Center or your local Siemens technical support representative.

Device

Siemens RAPIDPoint 400 Measurement Cartridge
  • Model / Serial
    Serial Numbers:2610900214 through 2621001325 Expiry Dates: Sept 13, 2016 through Dec. 6, 2016
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide: Foreign: Canada, Bahamas,Germany, Japan, Mexico.Belgium, Italy,Spain, Korea, France, Austria, Korea, France, Poland, Australia, china, AE, Bangladesh, Columbia, Czechkoslovakia, Bosnia
  • Product Description
    Siemens RAPIDPoint 400 Measurement Cartridge || Siemens SMN numbers:10329756, 10341161
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

Siemens Healthcare Diagnostics Inc
  • Manufacturer Address
    Siemens Healthcare Diagnostics Inc, 2 Edgewater Dr, Norwood MA 02062-4637
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA