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U.S. Department of Health and Human Services

Class 2 Device Recall Uritek TC101Urine Analyzer, catalog number TC101

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  Class 2 Device Recall Uritek TC101Urine Analyzer, catalog number TC101 see related information
Date Initiated by Firm December 22, 2005
Date Posted February 04, 2006
Recall Status1 Terminated 3 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
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 2		 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.
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