BEUDAMED
    FDA Recall Terminated

    Signify hCG Serum/Urine 30 Test Kit, Abbott List No. 07K09-30, ABI List No. 6026KSI, Lot# 84936, Exp 02/10/2007

    Recall: Z-1100-06 · Initiated May 5, 2006

    Recall

    Recall Number
    Z-1100-06
    Event Number
    35542
    Firm
    Applied Biotech Inc
    FEI Number
    1000125390
    Product Code
    JHI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 5, 2006
    Posted
    June 9, 2006
    Terminated
    February 29, 2012
    Address
    10237 Flanders Ct, San Diego, CA, 92121-2901

    Description

    Signify hCG Serum/Urine 30 Test Kit, Abbott List No. 07K09-30, ABI List No. 6026KSI, Lot# 84936, Exp 02/10/2007

    Reason

    Certain kits from the product lot may contain test devices which contain incorrect reaction strips. Use of such devices may produce false negative results with patient samples at and above the limit of detection of the product.

    Action

    Distribution records indicate that the above product lot was produced for sale to Abbott Laboratories and Abbott Laboratories received all of the product lot. A recall certified recall letter was mailed 05/08/06. Abbott was also instructed if they have further distributed any of the referenced product lot, please see that their accounts are contacted, advise them of the urgent notification, and instruct them to destroy any of the affected product lot.

    Distribution

    In US : IL

    Quantity

    1198 Kits (35,940 Test)