BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides per cartridge and 5 cartridges per box - 90 slides per box). LIPA Slides are processed by higher volume (or mainframe) VITROS Chemistry Systems typically used in hospital laboratories. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. 510(k) #: K845027 (18 January 1985). Shelf life: Cat. # 166 8409: 12/01/07, Cat. # 829 7749: 12/01/07-1/01/08

    Recall: Z-0245-2007 · Initiated October 9, 2006

    Recall

    Recall Number
    Z-0245-2007
    Event Number
    36512
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    CHI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 9, 2006
    Posted
    December 5, 2006
    Terminated
    May 22, 2008
    Address
    100 Indigo Creek Drive, Rochester, NY, 14626

    Description

    VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides per cartridge and 5 cartridges per box - 90 slides per box). LIPA Slides are processed by higher volume (or mainframe) VITROS Chemistry Systems typically used in hospital laboratories. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. 510(k) #: K845027 (18 January 1985). Shelf life: Cat. # 166 8409: 12/01/07, Cat. # 829 7749: 12/01/07-1/01/08

    Reason

    The firm identified circumstances in which biased results or calibration failures can be observed when using any lot of VITROS LIPA slides if they have been stored on the VITROS Chemistry Systems for more than 2 days.

    Action

    On 10/09/06, Ortho-Clinical Diagnostics sent "IMPORTANT DISTRIBUTOR NOTIFICATION" Letters and "Confirmation of Receipt" Forms via Federal Express to all distributor accounts informing them of the "field correction", and instructing them to inform their customers who received these slides of this issue. OCD foreign affiliates were informed of this action by e-mail on 10/09/06, and instructed them to inform their customers who received the LIPA slides of this "field correction". OCD also sent "IMPORTANT PRODUCT CORRECTION NOTIFICATION" Letters and "Confirmation of Receipt" Forms to US end-user consignees that received the LIPA slides directly from OCD via US Postal Service, informing them of this "field correction" and that they may continue to use their current lot of Coating 3235 LIPA Slides until replacement product arrived providing that they followed the instructions in the letter.

    Distribution

    Worldwide distribution

    Quantity

    Cat./REF # 166 8409: Domestic - 3031, Foreign - 2511; Cat./ REF # 829 7749: Domestic - 1682, Foreign - 3553