BEUDAMED
    FDA Recall Terminated

    Nichols IRMA Intact PTH Assay, catalog No. 40-2171

    Recall: Z-0809-05 · Initiated March 25, 2005

    Recall

    Recall Number
    Z-0809-05
    Event Number
    31493
    Firm
    Nichols Institute Diagnostics
    FEI Number
    2050095
    Product Code
    CEW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 25, 2005
    Posted
    May 10, 2005
    Terminated
    March 16, 2012
    Address
    1311 Calle Batido, San Clemente, CA, 92673-6316

    Description

    Nichols IRMA Intact PTH Assay, catalog No. 40-2171

    Reason

    Firm noted a change in performance and therefore changed the labeled performance specifications in the Directional Insert portion of the labeling.

    Action

    Firm sent customer notifications to firms on March 9 and 11, 2005 which were deemed not appropriate upon review by the FDA, firm agreed to resend notices approved by FDA on March 25, 2005 which requested that customers cease using the lots and destroy inventory for credit.

    Distribution

    Nationwide, Canada, Greece, Italy, Sweden, Austria, Balgium, Korea, Spain, Grea Britian, Taiwan, Finland, Denmark, New Zealand, Israel

    Quantity

    Not divulged