Events

Recall of Device Recall Siemens Healthcare Diagnostics

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
    68437
  • Event Risk Class
    Class 2
  • Event Number
    Z-2079-2014
  • Event Initiated Date
    2014-05-23
  • Event Date Posted
    2014-07-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127701
  • 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
    Acid, lactic, enzymatic method - Product Code KHP
  • Reason
    Rapidpoint 500 measurement cartridges may have an error code one or more electrolyte parameters (e.G., na+, ca++, k+, cl-).
  • Action
    Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on May 27, 2014 both in the United States and elsewhere for communication with affected customers. This notice informs customers of the issue with the RAPIDPoint 500 Measurement cartridges. Questions contact: Siemens Customer Care Center or your local Siemens technical support representative at 877-229-3711. What steps can be taken to mitigate the issue: " Install a new RAPIDPoint 500 Measurement Cartridge. or " Install a 405 Measurement Cartridge - The RAPIDPoint 405 cartridge is available in four sizes: Since the Lactate parameter is not available on the RAPIDPoint 405 cartridge, however, you will need to arrange to get your lactate results from other instruments in your central laboratory. or " Use an alternative system to obtain your electrolyte values.

Device

Device Recall Siemens Healthcare Diagnostics
  • Model / Serial
    Serial Numbers: 2334500011 through 2412705915
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: U.A.E. Albania Austria Australia Bosnia Herzeg. Belgium Bulgaria Bahrain Brazil Canada Switzerland P.R. China Colombia Czech Republic Germany Denmark Algeria Estonia Egypt Spain Finland France United Kingdom Georgia Greece Hong Kong Croatia Hungary Indonesia Ireland Israel India Italy Japan Republic Korea Kuwait Lithuania Luxembourg Latvia Malaysia Mexico Netherlands Norway New Zealand Peru Poland Portugal Qatar Romania Serbia Russian Fed. Saudi Arabia Sweden Singapore Slovenia Turkey Taiwan
  • Product Description
    RAPIDPoint 500 Measurement Clinical Chemistry System || RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) || Part number: 10491449; || RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) || Part Number: 10491448 || RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) || Part Number: 10491447 || RAPIDPoint 500 Measurement Cartridge Lactate (100 Tests) || Part Number:10844813
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

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