Class 2 Device Recall Urine Reagent Strips (URS) 10 Parameters

• Date Initiated by Firm: October 14, 2011
• Date Posted: January 11, 2012
• Recall Status: Terminated on April 09, 2013
• Recall Number: Z-0511-2012
• Recall Event ID: 60476
• Product Classification: Automated urinalysis system - Product Code KQO
• Product: Urine Reagent Strips (URS) 10 Parameters URS-l0-100W 510(K) number: K970250 Devise Listing number: D072377 Each device consists of 100 strips of Urine Reagent Strips 10 parameters packed with a desiccant pouch inside a gray bottle with Teco Diagnostics Label on the bottle and the bottle placed inside a Teco Diagnostics Box. For the semi-quantitative and qualitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes in urine.
• Code Information: Product/Catalog # 1: URS-l 0-100W i. Lot Number: 35264 ii. Expiration Date: 01/2014
• Recalling Firm/ Manufacturer: Teco Diagnostics; 1268 N Lakeview Ave; Anaheim CA 92807-1831
• For Additional Information Contact: Ms. Jenifer Ohta; 714-463-1111
• Manufacturer Reason for Recall: This recall was initiated in response to findings during a FDA inspection of the firm. The firm's recall has been initiated due to improper manufacture of sub-component nitrite paper Lot 35134, Expiration Date: 01/2014. Discrepancies were found on the information recorded on formulation sheet and manufacturing log sheets (Refer to next paragraph). Sampling size submitted for QC testing was insuff
• FDA Determined Cause: Nonconforming Material/Component
• Action: Teco Diagnostics sent an "URGENT: MEDICAL DEVICE RECALL" letter dated October 14, 2011 to affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructed customers to examine their inventory for the affected product and to quarantine any product found. A Recall Return Response Form was included with the letter for customers to complete and return. Contact the firm's Technical Support Department at (800) 222-9880 for questions regarding this recall.
• Quantity in Commerce: 550 kits
• Distribution: Distributed in CA and Poland.
• 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.