BEUDAMED
    FDA Recall Terminated

    OTC Pregnancy Test Kit labeled: ''CHOICE Pregnancy Test Kit'' (PA-320) , cassette type with cup and dropper. Label states: ''Easy to Use, Easy Reading, Positive result as early as 1 minute, Over 99% accurate.'' Each box contains one home test kit. Responsible firm on label: Distributed by: ICC, Amherst, NY 14228

    Recall: Z-0453-05 · Initiated October 7, 2004

    Recall

    Recall Number
    Z-0453-05
    Event Number
    30794
    Firm
    International Chemical Inc.
    FEI Number
    1319423
    Product Code
    LCX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 7, 2004
    Posted
    January 28, 2005
    Terminated
    October 13, 2005
    Address
    55 Woodridge Dr, Amherst, NY, 14228-2221

    Description

    OTC Pregnancy Test Kit labeled: ''CHOICE Pregnancy Test Kit'' (PA-320) , cassette type with cup and dropper. Label states: ''Easy to Use, Easy Reading, Positive result as early as 1 minute, Over 99% accurate.'' Each box contains one home test kit. Responsible firm on label: Distributed by: ICC, Amherst, NY 14228

    Reason

    Poor sealing of pouches and degradation of product. Invalid test results and false negatives are possible.

    Action

    The consignee (exporter) was notified via telephone in October 2004 regarding lot U040904 (cassette) and notified via telephone regarding the expanded recall (lot U060804, One-Step) on 12/27/2004. A recall letter issued regarding both lots on 1/10/2005.

    Distribution

    Product was shipped to an exporter in Florida who further distributed to consignees in the Caribbean.

    Quantity

    108