Class 2 Device Recall Teco Diagnostics Uritek TC101 Urine Analyzer

• Date Initiated by Firm: October 01, 2010
• Date Posted: December 09, 2010
• Recall Status: Terminated on August 03, 2012
• Recall Number: Z-0581-2011
• Recall Event ID: 57157
• Product Classification: Automated urinalysis system - Product Code KQO
• Product: Immunostics, Inc. Detector UriStrip Urine Analyzer, Catalog Number: Detector UriStrip Urine Analyzer; The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10.
• Code Information: All units sold (2005 - 2010)
• Recalling Firm/ Manufacturer: Teco Diagnostics; 1268 N Lakeview Ave; Anaheim CA 92807-1831
• For Additional Information Contact: 714-463-1111
• Manufacturer Reason for Recall: This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di
• FDA Determined Cause: Other
• Action: Teco Diagnostics initiated an "Urgent: Medical Device Recall" letter dated October 14, 2010, with an attached "Recall Return Response Form" to the affected consignees via US Postal on October 15, 2010. The recall notice informed the consignees of the reason for recall, the products affected and the actions required. Consignees were instructed to complete and return the enclosed Recall Return Response Form as soon as possible via mail, fax, or email. Upon receipt of the Recall Return Response Form, Teco Diagnostics would work with the consignees/distributors to process any refunds or reimbursements for the returned product and return shipping. If consignees/distributor had questions, they were to call Teco's Technical Support Department at (800) 222-9880 or (714) 463-1111.
• Quantity in Commerce: 2,140 units total for all products
• Distribution: Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, AND WV and the country of Canada.
• 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.