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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall MultiAnalyte Urine DAU Control (15 mL); see related information
Date Initiated by Firm August 05, 2011
Date Posted January 23, 2012
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = Lin-Zhi International, Inc.
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