Class 2 Device Recall Uritek TC101Urine Analyzer, catalog number TC101

• Date Initiated by Firm: December 22, 2005
• Date Posted: February 04, 2006
• Recall Status: Terminated on March 07, 2012
• Recall Number: Z-0472-06
• Recall Event ID: 34304
• Product Classification: Automated Urinalysis System - Product Code KQO
• Product: Uritek TC-101Urine Analyzer, catalog number TC-101
• Code Information: Serial# 200509001 through 200509050
• FEI Number: 1832216
• Recalling Firm/ Manufacturer: Teco Diagnostics; 1268 N Lakeview Ave; Anaheim CA 92807-1831
• For Additional Information Contact: Frank Morales; 714-693-7788 Ext. 108
• Manufacturer Reason for Recall: When reading the Nitrite parameter on the Teco Diagnostics URS-10 strips, some positive nitrite samples may be read by the machine as negative.
• FDA Determined Cause: Other
• Action: On December 22nd,2005 the firm sent the notification letter along with a replacement unit of TC-101. These letters and replacement units were send via Fed ex ground and the tracking numbers and serial numbers of the sent units are also noted. Also noted are the return authorization numbers assigned to each respective customer.
• Quantity in Commerce: 50
• Distribution: Nationwide
• 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.