Events

Recall of Device Recall Siemens Healthcare CLINITEK Status Analyzer

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
    67930
  • Event Risk Class
    Class 3
  • Event Number
    Z-1545-2014
  • Event Initiated Date
    2013-02-26
  • Event Date Posted
    2014-05-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126623
  • 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
    Automated urinalysis system - Product Code KQO
  • Reason
    Device with sample interference notes (sin) enabled not cleared for us marketing.
  • Action
    On February 26, 2013, a Siemens Field Engineer from Siemens Healthcare visited customer site and disabled the Sample Interference Notes feature on the instrument.

Device

Device Recall Siemens Healthcare CLINITEK Status Analyzer

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