BEUDAMED
    FDA Recall Open, Classified

    VITROS XT Chemistry Products TBIL-ALKP Slides

    Recall: Z-2623-2023 · Initiated August 5, 2023

    Recall

    Recall Number
    Z-2623-2023
    Event Number
    92928
    Firm
    Ortho-Clinical Diagnostics, INc.
    FEI Number
    1000305840
    Product Code
    CIG
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 5, 2023
    Posted
    September 21, 2023
    Address
    513 Technology Blvd, Rochester, NY, 14626-3601

    Description

    VITROS XT Chemistry Products TBIL-ALKP Slides

    Reason

    Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.

    Action

    An "IMPORTANT PRODUCT CORRECTION NOTIFICATION" letter dated 08/17/2023 was issued to impacted consignees. Consignees are provided instructions to utilize when reviewing sample results and any result between 600-1500 U/L should be diluted using a 10x dilution and retested. A confirmation of receipt of the recall letter should be completed and returned by August 25, 2023. Please forward this notification if the affected product was distributed outside your facility. Save this notification with your documentation or post this notification by each VITROS 250/350/FS 5,1/4600/5600/XT 3400/XT 7600 System until the issue has been resolved. If your laboratory has experienced this issue with the product and has not already done so, please report the occurrence to your local Ortho Care Technical Solutions Center. If you have further questions, please contact our Global Services Organization at 1-800-421-3311.

    Distribution

    Worldwide Distribution: US (nationwide) and OUS (foreign) distribution to countries of: Bermuda, Belgium, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, Italy, India, Japan, Mexico, Netherlands, Norway, Singapore, Spain, Sweden, Portugal, Russia, United Kingdom

    Quantity

    52,456 units