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U.S. Department of Health and Human Services

Class 3 Device Recall Single Analyte Urine DAU Control (5 m L

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  Class 3 Device Recall Single Analyte Urine DAU Control (5 m L see related information
Date Initiated by Firm October 03, 2013
Date Posted November 25, 2013
Recall Status1 Terminated 3 on December 26, 2013
Recall Number Z-0386-2014
Recall Event ID 66542
510(K)Number K081008  
Product Classification Drug specific control materials - Product Code LAS
Product Single Analyte Urine DAU Control (5 m L
Norbuprenorphine, Level II control
For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C.
Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative.

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

The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer. It in intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine.
Code Information Catalog #A68825, Lot #1307086; Exp. 3/28/2014/
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 # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentration reading due to the degradation of the NBUP analyte in solution.
FDA Determined
Cause 2		 Under Investigation by firm
Action Beckman Coulter sent a Manufacturer Field Action Letter dated November 2013, to the one distributor. The letter identified the product the problem and the action needed to be taken by the customer. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. If you have any questions regarding this notice, please contact our Customer Support Center ¿¿ Via our website, http://www.beckmancoulter.com/customersupport/support ¿¿ Via phone, call 1-800-854-3633 in the United States ¿¿ Outside the United States, contact your local Beckman Coulter Representative. We apologize for any inconvenience.
Quantity in Commerce 60 items
Distribution US Distribution in 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 = LAS and Original Applicant = Lin-Zhi International, Inc.
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