BEUDAMED
    FDA Enforcement Class II Ongoing

    VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);

    Recall: Z-2123-2025 · Reported July 23, 2025

    Enforcement

    Recall Number
    Z-2123-2025
    Event ID
    97047
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 23, 2025
    Initiation Date
    June 10, 2025
    Classification Date
    July 17, 2025
    Address
    100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States

    Description

    VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);

    Reason

    Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).

    Code Info

    Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides); UDI-DI: (1) 10758750030293, (2) 10758750030309; Lot Numbers: All lots within expiry.

    Distribution

    Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, GA, IL, MD, MI, MO, MS, NY, TN, TX, VA; and OUS (International) to countries of: Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, and United Kingdom.

    Quantity

    414,000 (OUS)