CLASS II Device recall · Reported 22 Oct 2014 · FDA Enforcement Report

External power supply adaptors that accompany Clinitek recalled

Siemens Healthcare Diagnostics is recalling External power supply adaptors that accompany Clinitek Status+ The Clinitek Status, distributed nationwide in the US. The recall was initiated on 19 Sep 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes10379675, 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

Quantity recalledapprox. 4200

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0081-2015
FDA event ID: 69228
Recalling firm: Siemens Healthcare Diagnostics, East Walpole, MA
Classification: Class II
Status: Terminated
Recall initiated: 19 Sep 2014
FDA classified: 16 Oct 2014
Reported: 22 Oct 2014
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

19 Sep 2014	Recall initiated by company
16 Oct 2014	Classified by FDA	+27 days
22 Oct 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Georgia Puerto Rico

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 69228

Reported	Class	Recall	Company	Reason	Where
22 Oct 2014	CLASS II	External power supply adaptors that accompany Clinitek recalled	Siemens Healthcare Diagnostics	Other	Nationwide
22 Oct 2014	CLASS II	External power supply adaptors that accompany Clinitek recalled	Siemens Healthcare Diagnostics	Other	Nationwide

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