BEUDAMED
    FDA Enforcement Class II Terminated

    CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001

    Recall: Z-0804-2021 · Reported January 13, 2021

    Enforcement

    Recall Number
    Z-0804-2021
    Event ID
    86951
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 13, 2021
    Initiation Date
    December 2, 2020
    Classification Date
    January 7, 2021
    Termination Date
    June 30, 2022
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025, United States

    Description

    CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001

    Reason

    Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results

    Code Info

    All serial numbers

    Distribution

    US Nationwide

    Quantity

    716,880 units