BEUDAMED
    FDA Enforcement Class II Ongoing

    VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740

    Recall: Z-0535-2025 · Reported December 4, 2024

    Enforcement

    Recall Number
    Z-0535-2025
    Event ID
    95634
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    December 4, 2024
    Initiation Date
    October 11, 2024
    Classification Date
    November 25, 2024
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101, United States

    Description

    VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740

    Reason

    May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to know if the sample has to be diluted to measure again.

    Code Info

    UDI/GTIN 10758750000296 Coating 1221, expiration date 10/01/2024 Coating 1222, expiration date 01/01/2025

    Distribution

    Worldwide - US Nationwide distribution in the states of AZ, FL, ID, IL, KS, MN, MT, NY, PA, UT and the countries of Australia, Belgium, Bermuda, Brazil, Canada L3R 0B8, Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.

    Quantity

    7717 units