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U.S. Department of Health and Human Services

Class 2 Device Recall MultiAnalyte Urine DAU Cutoff Calibrator

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  Class 2 Device Recall MultiAnalyte Urine DAU Cutoff Calibrator see related information
Date Initiated by Firm August 23, 2011
Date Posted January 25, 2012
Recall Status1 Terminated 3 on January 25, 2012
Recall Number Z-0868-2012
Recall Event ID 60743
510(K)Number K051088  
Product Classification Calibrators, drug mixture - Product Code DKB
Product Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box)
For in vitro diagnostic use only.

Lin-Zhi International, Inc..
670 Almanor Ave.
Sunnyvale, CA 94085

intended use: Drug abuse detection.
Code Information Catalog number 0803; Lot 1101136K3, exp 1/28/13
Recalling Firm/
Lin-Zhi International Inc
670 Almanor Ave
Sunnyvale CA 94085-3513
For Additional Information Contact Annie Hung
Manufacturer Reason
for Recall
Multi Analyte Urine DAU Cutoff Calibrator Gives a decreased absorbance reading due to a loss of the BZO (oxazepam) analyte from the solution and may cause false positive readings.
FDA Determined
Cause 2
Nonconforming Material/Component
Action The firm, Lin-Zhi International, Inc., sent a notice by email dated August 23, 2011 to all customers. The notice described the product, problem and actions to be taken. Lin-Zhi will contact the customers to determine whether they want replacement BZO calibrators and controls immediately or if they are willing to wait a minimum of four weeks for a new lot of the Multi-Analyte Urine Cutoff Calibrators. The customers were instructed to contact Lin-Zhi with their replacement request. The notice also stated that the Lin-Zhi has plans to create more stringent QC standards and further R&D regarding stabilization of this analyte in solution in its calibrators of controls containing BZO. If you have any questions or concerns regarding how this situation is being handled or the outcome, contact Lin-Zhi at (408)732-3856; email: customerservice@lin-zih.com or webpage: www.lin-zhi.com.
Quantity in Commerce 45 items
Distribution Worldwide distribution: USA (nationwide) including states of: AL, FL, GA, IN, NC, NH, and TX; and country of: 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 = DKB and Original Applicant = Lin-Zhi International, Inc.