BEUDAMED
    FDA Enforcement Class III Terminated

    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: Z-1270-2014 · Reported April 2, 2014

    Enforcement

    Recall Number
    Z-1270-2014
    Event ID
    67607
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Lin-Zhi International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 2, 2014
    Initiation Date
    February 18, 2014
    Classification Date
    March 21, 2014
    Termination Date
    April 25, 2014
    Address
    670 Almanor Ave, N/A, Sunnyvale, CA, 94085-3513, United States

    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

    Reason

    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).

    Code Info

    Product catalog number: A68827; Lots 1308006, 1308131, Expiry: March 28, 2015.

    Distribution

    US Distribution including CA.

    Quantity

    120 units, 60 of each lot number