FDA-Device2014-10-22Class II
External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.
Siemens Healthcare Diagnostics, Inc
Hazard
The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.
Sold states
Worldwide Distribution - USA (nationwide) including Puerto Rico and Internationally Canada, Mexico, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Latvia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed., Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, Sweden, Switzerland, Tadjikistan, Taiwan, Turkey, Turkmenistan, Unit.Arab Emir., United Kingdom, Vietnam.
Affected count
approx. 4200
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0081-2015Don't want to check this manually?
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