BEUDAMED
    FDA Recall Terminated

    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.

    Recall: Z-1946-2015 · Initiated March 20, 2015

    Recall

    Recall Number
    Z-1946-2015
    Event Number
    70992
    FEI Number
    3002808140
    Product Code
    LPS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 20, 2015
    Posted
    July 1, 2015
    Terminated
    October 27, 2015
    Address
    Axis-Shield Diagnostics, Ltd. The Technology Park Luna Place Dundee United Kingdom

    Description

    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.

    Reason

    Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.

    Action

    Axis Shield sent an Urgent Field Safety Notice letter dated March 20, 2015 to their customers via email and written notice sent with confirmed delivery receipt. The letter identified the affected product, problem and actions to be taken. Recommended Action to Customer is as follows: Confirm receipt of FSN to Axis-Shield. Do not use the affected Reagent lots referenced in the safety notice. In the event of holding one of the affected lots, immediately contact Axis-Shield Product Support Department to arrange for replacement material and return any defective product to Axis-Shield. Complete reconciliation form. Complete acknowledgement of the safety notice within 10 working days. Ensure safety notice has been distributed and reviewed by all appropriate personnel within your organization. If further distribution of affected lots to another organization has been made, inform them of this Product Recall and provide a copy of this safety notice to them. Retain a copy of the safety notice for their records. For any issues or concerns contact Axis-Shield via e-mail; MDL-AXD-Product- [email protected].

    Distribution

    Worldwide Distribution - US Nationwide in the states of: KY, WA, CA, and PA and the country of Germany.

    Quantity

    52 kits + 75 kits Beckman Coulter Brand OUS