BEUDAMED
    FDA Recall Terminated

    RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use.

    Recall: Z-1158-04 · Initiated June 29, 2004

    Recall

    Recall Number
    Z-1158-04
    Event Number
    29485
    Firm
    PerkinElmer LAS Inc
    FEI Number
    1522510
    Product Code
    JBD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 29, 2004
    Posted
    July 23, 2004
    Terminated
    October 29, 2008
    Address
    3985 Eastern Rd, Norton, OH, 44203-6215

    Description

    RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use.

    Reason

    Hemoglobin Test Kit Catholyte Solution generating false positive results, were distributed.

    Action

    The firm contacted their customers via telephone and notified them of the recall on 6/29/2004. A follow-up recall letter was also issued on 6/29/2004. The letter requests that the customer either destroy the product or return it to the firm for replacement. Also attached for completion and to be faxed back to the recalling firm, is a questionaire which documents the customer''s receipt of the product and recall letter; any reports of illness or injury in connection with the use of the product; and the customer''s proposed disposition of the kits i.e. return or destruction. Additional follow-up with all non-responding customers will take place in 2 weeks.

    Distribution

    The recalled kits were distributed to customers in the following locations: FL, OK, GA, MD, AZ, KY, NY, PR, OR, NJ, WA, MI, KS, AR, IN, TX, MN, CA, VA, NC, DE, UT, WI, SC, OH, MT, KS, CO & PR.

    Quantity

    146