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Recall Observatory FDA recall evidence

Device product

External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.

Z-0081-2015

September 19, 2014

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc
Event
Event 69228
Status
Terminated
Classification
Class II
Quantity
approx. 4200
Official record key
device-enforcement:Z-0081-2015

Official wording

Reason: 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.

Code information: 10379675, 10379676, 10379677, 10379678, 10379679, 10379680, 10379681, 10376324; (Legacy P/N: 1780) Power supply adaptors embossed with the following 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, 23140

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.

Field note

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