Events

Safety Alert for CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect Systems

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Siemens.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-09-30
  • Event Date Posted
    2014-09-30
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140930.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: siemens clinitek status, clinitek status+, and clinitek status connect systems medicines and healthcare products regulatory agency (mhra), united kingdom, has issued a medical device safety alert concerning clinitek status, clinitek status+, and clinitek status connect systems, manufactured by siemens. the material numbers of affected products are identified as follows: clinitek status+: 10379675; 10379676; 10379677; 10379678; 10379679; 10379680; 10379681; 10697813; 10376324 (legacy p/n: 1780), clinitek status connect system: 10376322; 10376323 (legacy p/n: 1790); 10470849 (legacy p/n: 1797), clinitek status power supply adaptor – spare part: 10378632; 10378633; 10378634;10309177; 10309178; 10324040; 10376820 this affects power supply adaptors embossed with the numerical date codes: 50130, 51130, 52130, 01140, 02140, 03140, 04140, 05140, 06140, 07140, 08140, 09140, 10140, 11140, 12140, 13140, 14140, 15140, 16140, 17140, 18140, 19140, 20140, 21140, 22140, and 23140. the manufacturer has received customer complaints regarding damage to the external power supply adaptors that accompany the clinitek status, clinitek status+, and clinitek status connect urine analyzers, which can result in an increased potential for electric shock to the user. affected users are advised to discard all affected/ damaged adaptors. for clinitek status or clinitek status+ customers, instrument can still be run by battery power. affected users are suggested to consult operator’s guide for instructions. clinitek status connect systems, however, cannot be operated on battery power. for details, please refer to the following mhra website:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con457620 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 sep 2014.

Device

CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect Systems
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Siemens CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect Systems
  • Manufacturer
    Siemens

Manufacturer

Siemens