BEUDAMED
    FDA Recall Terminated

    LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit Immunofluorescence Assay Cat. No. 3121 FOR IN VITRO DIAGNOSTIC USE Authorized Representative: Millipore (UK) Ltd. Fleming Road, Kirkton Campus Livingston EH54 7BN UK. Tel +44 1506 404000 Fax +44 1506 404073 MILLIPORE 28820 Single Oak Drive Temecula, CA 92590 " USA & Canada Phone: +1(800) 437-7500 " Fax: +1 (951) 676-9209. The kit consists of Catalog #5250 Simulfluor Flu A/B; Catalog #5010 Flu A/B Control Slide; Catalog #5013 Mounting Fluid; Catalog #5037 Tween 20/Sodium Azide, 100X; Catalog #5087 PBS Packet

    Recall: Z-0953-2009 · Initiated November 24, 2008

    Recall

    Recall Number
    Z-0953-2009
    Event Number
    50511
    Firm
    Millipore Corporation
    FEI Number
    2024094
    Product Code
    GNW
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    November 24, 2008
    Posted
    March 6, 2009
    Terminated
    August 10, 2012
    Address
    28820 Single Oak Dr, Temecula, CA, 92590-3607

    Description

    LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit Immunofluorescence Assay Cat. No. 3121 FOR IN VITRO DIAGNOSTIC USE Authorized Representative: Millipore (UK) Ltd. Fleming Road, Kirkton Campus Livingston EH54 7BN UK. Tel +44 1506 404000 Fax +44 1506 404073 MILLIPORE 28820 Single Oak Drive Temecula, CA 92590 " USA & Canada Phone: +1(800) 437-7500 " Fax: +1 (951) 676-9209. The kit consists of Catalog #5250 Simulfluor Flu A/B; Catalog #5010 Flu A/B Control Slide; Catalog #5013 Mounting Fluid; Catalog #5037 Tween 20/Sodium Azide, 100X; Catalog #5087 PBS Packet

    Reason

    Certain lots of Simulfluor Flu A / Flu B Reagent may cross-react with Respiratory Synctial Virus. The continued use of Simulfluor Flu A / Flu B Reagent Catalog #5250 may lead to a potential misdiagnosis of influenza B.

    Action

    Millipore is performing a voluntary recall by notifying customers and distributors by telephone on November 24, 2008. In addition, an Urgent: Medical Device Recall notification letter with the same date was sent via certified mail. Customers were advised to examine their stock immediately and discontinue the use of the specified lots. Customers were instructed to complete the enclosed Effective Check Survey confirming disposal of defective lots and return this form to Millipore's Regulatory Department. Customer service is to be contacted at 1-800-437-7500 for replacement product. Millipore Corporation will issue credit or replace the recalled lots that customers currently have in inventory.

    Distribution

    Worldwide Distribution -- USA including states of AL, CA, CO, CT, FL, ID, IL, KS, MA, MI, MS, NM, NY, OH, OK, OR, PA, SD, TX, UT, VA, VT, WA, WV, and WI and countries of Canada, Mexico, Italy, Belgium,Germany, France, Spain, and United Kingdom.

    Quantity

    404 units