Class 2 Device Recall Drugs of abuse urinalysis (DAU) cTHC (Cannabinoid) Control Level 1 (37.5ng/ml)

• Date Initiated by Firm: February 06, 2014
• Date Posted: March 12, 2014
• Recall Status: Terminated on March 10, 2015
• Recall Number: Z-1178-2014
• Recall Event ID: 67521
• 510(K)Number: K021449
• Product Classification: Calibrators, drug specific - Product Code DLJ
• Product: Cannabinoids DAU Calibrator Control Level 1; (37.5 ng/mL); This solution is prepared from non-sterile urine and should be handled as potentially infectious.; IVD;; ; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free; matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC,¿ 10% by GC/MS or LC/MS analysis.; ; Lin Zhi International inc.; Sunnyvale, CA 94085; ; The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.
• Code Information: Catalog number 0007Cm; lot number 1211158R; Expiration May 14, 2014.
• Recalling Firm/ Manufacturer: Lin-Zhi International Inc; 670 Almanor Ave; Sunnyvale CA 94085-3513
• For Additional Information Contact: Annie Ko; 408-732-3856
• Manufacturer Reason for Recall: Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards the end of their shelf life due to use of dated but unexpired secondary stock used to create the products.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Lin-Zhi International, sent an Recall letter dated February 6, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The Recall letter identified the product by catalog number and product description as well as lot numbers. The reason for recall is explained and that the issue was confirmed by Lin Zhi Quality Control. The 2 affected lots were made with unexpired but dated secondary stock that is the cause of the problem. Lin Zhi requests that customers inform laboratories and customers to properly dispose of any of the affected lots that are still in use or unopened. Lin Zhi should be notified of the amounts for credit. Questions should be directed to 408-732-3883.
• Quantity in Commerce: 130 items
• Distribution: US Distribution including the states of SC, NC, LA, FL, TX,, AL and GA and Internationally to Germany.
• 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 = DLJ and Original Applicant = Lin-Zhi International, Inc.