BEUDAMED
    FDA Recall Terminated

    Premier Platinum brand HpSA, diagnostic test kits, one kit per pouch, one pouch per shipping box.

    Recall: Z-0465-03 · Initiated December 26, 2002

    Recall

    Recall Number
    Z-0465-03
    Event Number
    25295
    Firm
    Meridian Bioscience Inc
    FEI Number
    1524213
    Product Code
    LYR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 26, 2002
    Posted
    January 23, 2003
    Terminated
    March 29, 2004
    Address
    3471 River Hills Dr, Cincinnati, OH, 45244

    Description

    Premier Platinum brand HpSA, diagnostic test kits, one kit per pouch, one pouch per shipping box.

    Reason

    Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.

    Action

    The firm mailed notices to their affected customers on 12/26/2002. The consignees were instructed to visually and physically inspect the seals on each microwell pouch for gaps. If properly sealed, the use of the microwells may be continued. Test wells in pouches with defective seals are to be quarantined and destroyed. The customers are asked to report back to the firm. All test microwell plates in defective pouches will be replaced by the firm.

    Distribution

    The kits were distributed to end-users and distributors located nationwide; and to foreign distributors located in China, Guatemala, New Zealand, Hong Kong, Mexico, Great Britain, Belgium, Italy, Brazil, Australia, Canada, Thailand, Honduras, and Japan.

    Quantity

    1,020 kits