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U.S. Department of Health and Human Services

Class 2 Device Recall MultiAnalyte Urine DAU Intermediate Calibrator

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  Class 2 Device Recall MultiAnalyte Urine DAU Intermediate Calibrator see related information
Date Initiated by Firm October 11, 2011
Date Posted January 25, 2012
Recall Status1 Terminated 3 on January 25, 2012
Recall Number Z-0847-2012
Recall Event ID 60757
510(K)Number K051088  
Product Classification Calibrators, drug mixture - Product Code DKB
Product Multi-Analyte Urine DAU Calibrator (15 mL);
Multi-Analyte,Intermediate Calibrator;
for in-vitro diagnostic use only.
Contains 300 ng/mL benzoylecgonine, 750 ng/mL d-methamphetamine, 4000 ng/m: morphine, 50 phencyclidine, 500 ng/m: oxazepam, 500 ng/mL secobarbital, 700ng/mL propoxyphene and 600 ng.mL methadone in urine buffer with dosium azide as preservitive.

Drug abuse testing

Lin-Zhi International, Inc.'
670 Almanor Ave.
Sunnyvale, CA 94085.
Code Information Catalog 0804; lot number 1101138K2, 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		 Catalog # 0804 Multi-Analyte Urine DAU Intermediate Calibrators were incorrectly labeled and mistakenly filled with Catalog # 0805 DAU High Calibrators.
FDA Determined
Cause 2		 Labeling mix-ups
Action Lin -Zhi International sent a Recall letter dated October 11, 2011, and a e-mail to all affected customers. This was followed up by a personal phone call from Lin-Zhi personnel. The letter identified the product the problem and the action needed to be taken by the customer. The customer will be contacted to determine whether or not they were affected by this non-conformity. If they have been affected, they will be offered replacement Multi-Analyte Urine Intermediate Calibrators which are currently estimated to have a four week wait time before they become available. For further questions please call (408) 732-3856.
Quantity in Commerce 49 items
Distribution Worldwide Distribution -- USA (nationwide) including the states of NC,MA, NH and TX. and the 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.
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