Class 2 Device Recall MultiAnalyte Urine DAU Control (15 mL);

• Date Initiated by Firm: August 05, 2011
• Date Posted: January 23, 2012
• Recall Status: Terminated on January 23, 2012
• Recall Number: Z-0838-2012
• Recall Event ID: 60691
• 510(K)Number: K051088
• Product Classification: Drug mixture control materials - Product Code DIF
• Product: Multi-Analyte Urine DAU Control (15 mL); Level 2, For in-vitro diagnostic use only. Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 Multi-Analyte Urine Drug of Drug Abuse (DAU) Controls are for use as controls in the quantitative and semi-quantitative calibration of Amphetamines Enzyme, Opiate Enzyme, Phencyclidine Enzyme, Cocaine Metabolite Enzyme, Benzodiazepine Enzyme, Barbiturate Enzyme, Methadone Enzyme and Propoxyphene Enzyme on a number of automated clinical analyzers.
• Code Information: Catalog # 0808, lot number 1101137, Exp 1/28/2013
• Recalling Firm/ Manufacturer: Lin-Zhi International Inc; 670 Almanor Ave; Sunnyvale CA 94085-3513
• For Additional Information Contact: Annie Hung; 408-732-3856
• Manufacturer Reason for Recall: Customer complaint investigation found that the Multi-Analyte Urine DAU Level 2 control was incorrectly labeled and actually contained Multi-Analyte DAU Low Level Calibrators.
• FDA Determined Cause: Error in labeling
• Action: Lin Zhi International, Inc. sent a Recall notification letter dated August 5, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to determine whether they wanted credit or a replacement product. The incorrectly labeled product should be disposed of properly. For questions regarding this recall call 408-732-3856.
• Quantity in Commerce: 107 items kitted
• Distribution: Nationwide Distribution including MA, FL, NC, NH, WA, and IN.
• 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 = DIF