BEUDAMED
    FDA Recall Terminated

    Medplus ER Drug Screen Test Model #5800KAB packaged as 25 individually pouched devices in a labeled kit box.

    Recall: Z-1315-06 · Initiated May 31, 2005

    Recall

    Recall Number
    Z-1315-06
    Event Number
    35656
    Firm
    Applied Biotech Inc
    FEI Number
    1000125390
    Product Code
    LCM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 31, 2005
    Posted
    August 1, 2006
    Terminated
    July 25, 2012
    Address
    10237 Flanders Ct, San Diego, CA, 92121-2901

    Description

    Medplus ER Drug Screen Test Model #5800KAB packaged as 25 individually pouched devices in a labeled kit box.

    Reason

    The firm has discovered that a number of distributed devices of the Medplus ER Drug Screen Test may be incorrectly assembled which may give incorrect results. The product is an in vitro test for rapid detection of various drugs such as Amphetamines, Barbiturates, Phencyclidine, Cocaine, Methamphetamine, Tricyclic Antidepressants, Morphine, Tetrahydrocannabinol, & Benzodiazepines in human urine.

    Action

    Recall notifications that describe the problem, dated May 31,2005, were sent via fax. Customers were instructed to block all stock of affected lots in their warehouse, contact their primary consignees and advise them to discontinue use immediately and dispose any unused materials. A faxback form was used to communicate to the recalling firm the quantity blocked and disposed of. Arrangements were made for providing replacement product.

    Distribution

    Nationwide (distributors in KS and OR).

    Quantity

    Lot #85699: 71 kits (1775 devices) & Lot #85671: 44 kits (1100 devices)