Class 2 Device Recall Clinitek Status

• Date Initiated by Firm: September 19, 2014
• Date Posted: October 17, 2014
• Recall Status: Terminated on July 20, 2015
• Recall Number: Z-0081-2015
• Recall Event ID: 69228
• 510(K)Number: K091216
• Product Classification: Method, enzymatic, glucose (urinary, non-quantitative) - Product Code JIL
• Product: External power supply adaptors that accompany Clinitek Status+; ; The Clinitek Status systems is a urine analyzer.
• 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
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc; 333 Coney St; East Walpole MA 02032-1516
• For Additional Information Contact: 877-229-3711
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JIL and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS