BEUDAMED
    FDA Recall Terminated

    VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.

    Recall: Z-0268-2020 · Initiated September 10, 2019

    Recall

    Recall Number
    Z-0268-2020
    Event Number
    83879
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000305840
    Product Code
    CGZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 10, 2019
    Terminated
    November 13, 2020
    Address
    513 Technology Blvd, Rochester, NY, 14626-3601

    Description

    VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.

    Reason

    Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.

    Action

    On September 10, 2019, the firm distributed Urgent Product Correction Notification letters to affected customers. Customers were asked to take the following actions: "Complete and return the Confirmation of Receipt form. "If you experience a slide dispense issue, try to reposition the ABP by following the instructions in the enclosed Resolving Slide Dispense Issues document. Please place the instructions by each VITROS System in your facility that processes Microslides. "If you are unable to reposition the ABP, remove the affected cartridge and replace it with a new one. Complete and return the Request for Credit form as needed to receive credit for the slides remaining within affected and discarded cartridges. "Please forward this notification if the product was distributed outside of your facility. The firm will provide credit for the slides remaining within affected cartridge for which you are unable to reposition the ABP. If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.

    Distribution

    Domestic distribution nationwide. Foreign distribution to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, the Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, and United Kingdom.

    Quantity

    1365545 total