BEUDAMED
    FDA Recall Terminated

    ABX Diagnostics Minotrol 16 Hematology Controls, Normal and High, in vials distributed by ABX Diagnostics, Irvine, CA; and Horiba LC-TROL 16 (Hematology Reference Controls), Normal and High, in vials distributed by Horiba Ltd., Kyoto, Japan

    Recall: Z-0992-04 · Initiated April 15, 2004

    Recall

    Recall Number
    Z-0992-04
    Event Number
    29044
    Firm
    R & D Systems, Inc
    FEI Number
    2182501
    Product Code
    JPK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 15, 2004
    Posted
    July 20, 2004
    Terminated
    June 24, 2004
    Address
    614 Mckinley Pl Ne, Minneapolis, MN, 55413-2610

    Description

    ABX Diagnostics Minotrol 16 Hematology Controls, Normal and High, in vials distributed by ABX Diagnostics, Irvine, CA; and Horiba LC-TROL 16 (Hematology Reference Controls), Normal and High, in vials distributed by Horiba Ltd., Kyoto, Japan

    Reason

    Clots in hematology controls resulted in low red blood cell counts when used in blood analyzers because control values were outside the expected range due to the clotting which took place after manufacturing.

    Action

    Recall letters dated April 15, 2004 instructed consignees not to use the products to verify their analyzers and stated that the recalling firm is working on providing replacement products.

    Distribution

    The products were shipped to California, France and Japan.

    Quantity

    29494 vials of the normal controls and 15196 of the high controls