BEUDAMED
    FDA Recall Terminated

    IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma. Ref: AC-57F1 Lot 60897 Exp 2009-08; Immunodiagnostic Systems Ltd, Unit 10, Boldon Business Park, Boldon, Tyne & Wear, NE35. 9PD, UK. Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma

    Recall: Z-0173-2009 · Initiated August 2, 2008

    Recall

    Recall Number
    Z-0173-2009
    Event Number
    49393
    Firm
    Immunodiagnostics Systems Inc
    FEI Number
    3004046329
    Product Code
    MRG
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 2, 2008
    Posted
    October 24, 2008
    Terminated
    August 13, 2012
    Address
    17029 E Enterprise Dr, Ste 1, Fountain Hills, AZ, 85268

    Description

    IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma. Ref: AC-57F1 Lot 60897 Exp 2009-08; Immunodiagnostic Systems Ltd, Unit 10, Boldon Business Park, Boldon, Tyne & Wear, NE35. 9PD, UK. Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma

    Reason

    A small number of customers have experienced low absorbance values when using kits from this batch.

    Action

    All customers who received 25-Hydroxy Vitamin D EIA lot # 60897 were contacted by mail. Customers were instructed to sign a confirming document for having received the notification letter and return via fax. Customers are requested to contact Immunodiagnostic System Inc's office if they have any kits of 60897 remaining in stock. Rather than replacing only the biotin buffer as stated in the letter dated August 2, 2008, Immunodiagnostic Systems Inc. will replace the kit per the letter dated August 8, 2008. Contact Immunodiagnostic System Inc. at 1-480-836-7435 for assistance.

    Distribution

    Nationwide

    Quantity

    691 kits