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U.S. Department of Health and Human Services

Class 3 Device Recall Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator

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  Class 3 Device Recall Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator see related information
Date Initiated by Firm February 18, 2014
Date Posted March 21, 2014
Recall Status1 Terminated 3 on April 25, 2014
Recall Number Z-1270-2014
Recall Event ID 67607
510(K)Number K081008  
Product Classification Enzyme immunoassay, opiates - Product Code DJG
Product Single Analyte DAU Calibrator (5 mL)
Norbuprenorphine: Cutoff Calibrator;
IVD - for in vitro diagnostic use only;
Lin-Zhi International
Sunnyvale, CA

The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer
Code Information Product catalog number: A68827; Lots 1308006, 1308131, Expiry: March 28, 2015.
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		 Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. The cutoff calibrator was recovering at a concentration close to the NBUP Control Level 1 (7 ng/mL).
FDA Determined
Cause 2		 Packaging
Action Lin-Zhi International sent a Recall letter dated February 18, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Letters acknowledge that Lin Zhi was notified by the customer that the product could not be qualified and that this was confirmed by Lin-Zhi internal testing. Letters request that the distributor notify all customers of the situation and ask them to destroy any remaining product from the affected lots. the root cause is identified and letters also state that a corrective action has been implemented to prevent future problems. Questions may be directed to Lin Zhi International at 408-732-3856.
Quantity in Commerce 120 units, 60 of each lot number
Distribution US Distribution including CA.
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 = DJG and Original Applicant = Lin-Zhi International, Inc.
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