BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated October 11, 2024

    Recall

    Recall Number
    Z-0535-2025
    Event Number
    95634
    Firm
    Ortho-Clinical Diagnostics, Inc.
    FEI Number
    1000136573
    Product Code
    DCK
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 11, 2024
    Posted
    November 25, 2024
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    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.

    Action

    QuidelOrtho issued Urgent Product Correction Notification letter on 10.21.24. Letter states reason for recall, health risk and action to take: " Discontinue using, render unusable, and discard all remaining inventory of lots manufactured from the affected coating(s) of VITROS Chemistry Products CRP Slides. " Complete and return the enclosed Confirmation of Receipt form. Upon receipt of your completed Confirmation of Receipt form, QuidelOrtho will credit or replace your discarded inventory. " Save this notification with your User Documentation or post this notification by each VITROS 250/350/5,1 FS/4600/5600/XT 3400/XT 7600 System in your laboratory until the issue has been resolved. " Please forward this notification if the affected product was distributed outside of your facility. " If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Global Services Organization. Root Cause Our investigation is ongoing; however, additional testing has been implemented in our release process to mitigate this issue prior to the release of future coatings of VITROS CRP Slides

    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