BEUDAMED
    FDA Recall 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 · Initiated February 18, 2014

    Recall

    Recall Number
    Z-1270-2014
    Event Number
    67607
    Firm
    Lin-Zhi International Inc
    FEI Number
    3003610499
    Product Code
    DJG
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    February 18, 2014
    Posted
    March 21, 2014
    Terminated
    April 25, 2014
    Address
    670 Almanor Ave, Sunnyvale, CA, 94085-3513

    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).

    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.

    Distribution

    US Distribution including CA.

    Quantity

    120 units, 60 of each lot number