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U.S. Department of Health and Human Services

Enforcement Report - Week of April 2, 2014

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Product Detail

Product Description 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
Recall Number Z-1270-2014
Classification Class III
Code Info Product catalog number: A68827; Lots 1308006, 1308131, Expiry: March 28, 2015.
Product Distributed Qty 120 units, 60 of each lot number
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).

Event Detail

Event Id 67607
Product Type Devices
Status Ongoing
Recalling Firm Lin-Zhi International Inc
City Sunnyvale
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-18
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern US Distribution in state of: CA.