Class 3 Device Recall Siemens Healthcare CLINITEK Status Analyzer

• Date Initiated by Firm: February 26, 2013
• Date Posted: May 04, 2014
• Recall Status: Terminated on May 06, 2014
• Recall Number: Z-1545-2014
• Recall Event ID: 67930
• 510(K)Number: K091216
• Product Classification: Automated urinalysis system - Product Code KQO
• Product: CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
• Code Information: Serial Number: 212809
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics Inc; 2 Edgewater Drive; Norwood MA 02062
• For Additional Information Contact: 781-269-3000
• Manufacturer Reason for Recall: Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
• FDA Determined Cause: Reprocessing Controls
• Action: On February 26, 2013, a Siemens Field Engineer from Siemens Healthcare visited customer site and disabled the Sample Interference Notes feature on the instrument.
• Quantity in Commerce: 1 unit
• Distribution: US Distribution in the state of: CA.
• 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 = KQO