BEUDAMED
    FDA Recall Terminated

    CA15-3 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.

    Recall: Z-1629-2011 · Initiated December 22, 2010

    Recall

    Recall Number
    Z-1629-2011
    Event Number
    57506
    Firm
    BioCheck Inc
    FEI Number
    3002564473
    Product Code
    LTK
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    December 22, 2010
    Posted
    March 11, 2011
    Terminated
    March 25, 2011
    Address
    323 Vintage Park Dr, Foster City, CA, 94404-1186

    Description

    CA15-3 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.

    Reason

    Product labels indicate that the products are for IVD use and they do not have an approved 510(k).

    Action

    The firm, BioCheck, sent an "URGENT: DEVICE RECALL" letter dated December 22, 2010 to all customers. The letter described the product, problem and actions to be taken by customers. The customer were instructed to examine their inventory for the affected lots, if found, discontinue distributing the lots and promptly return via Fedex to BioCheck at 323 Vintage Park Drive, Foster City, CA 94404, Attn: RETURNED GOODS; immediately contact their accounts, if they further distributed the product, and inform them of the Recall, and complete and return the response form via email at: [email protected] or fax to (650-573-1969) immediately. If you have any questions, please call (650) -573-1968 anytime during office hours (8:30am to 5:30pm Pacific time).

    Distribution

    Nationwide distribution.