Z-0083-2015Class II

External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek...

Name: Z-0083-2015 External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2014-09-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-09-19 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer on 2014-09-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0083-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-19
Posted: 2014-10-17
Terminated: 2015-07-20
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer.
Product code: JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Siemens sent an Urgent Field Safety Notice dated September 2014, to all by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on September 19, 2014 both in the United States and elsewhere for communication with affected customers. This notice informs customers of the issue with the power supply and the potentially affected products that may contain a damaged power supply. Consignees are asked to complete a Field Correction Effectiveness Check form and return in to Siemens Healthcare Diagnostics via Fax to (312) 275-7795. All affected domestic customers were sent a hard copy of the Urgent Field Safety Notice via Federal Express on 9/23/14. All affected customers outside the US will be provided a copy of an Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each countries local regulations and procedures. Customers with questions were instructed to contact their local Siemens technical support representative. For questions regarding this recall call 877-229-3711.
Quantity in commerce: approx. 4200
Distribution: 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.
Product codes and lots: 10378632, 10378633, 10378634, 10309177, 10309178, 10324040, 10376820 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0083-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0081-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-22	2014-10-16
Z-0082-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-22	2014-10-16
Z-0083-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-22	2014-10-16

Product code JIL

K091216Class IIClinitek Status+analyzer and Clinitek Status Connect System, Models 1780, 1797Siemens Healthcare Diagnostics / cleared 2009-10-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)