BEUDAMED
    FDA Recall Terminated

    DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laboratories.

    Recall: Z-1478-2011 · Initiated March 1, 2010

    Recall

    Recall Number
    Z-1478-2011
    Event Number
    55293
    Firm
    Bio-Rad Laboratories Inc
    FEI Number
    2915274
    Product Code
    LKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 1, 2010
    Posted
    March 2, 2011
    Terminated
    March 11, 2011
    Address
    4000 Alfred Nobel Dr, Hercules, CA, 94547-1803

    Description

    DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laboratories.

    Reason

    Inaccurate results-- Consumer complaints of increased positivity rates with the ANA screening kit.

    Action

    Recall was initiated on 3/1/2010. DiaSorin S.R.I. (the sole consignee) was alerted via email using the firm's Medical Device Recall Notification. Consignee informed of the recall and instructed to dispose of the affected product according to local laws.

    Distribution

    Foreign Only: One distributor, DiaSorin S.R.I. in Italy. No wholesalers. No retailers. No domestic distribution, No Federal Government sales/distribution centers.

    Quantity

    999 kits