BEUDAMED
    FDA Enforcement Class II Ongoing

    Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

    Recall: Z-1595-2021 · Reported May 26, 2021

    Enforcement

    Recall Number
    Z-1595-2021
    Event ID
    87705
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    FAX
    Report Date
    May 26, 2021
    Initiation Date
    April 7, 2021
    Classification Date
    May 14, 2021
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

    Reason

    Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed.

    Code Info

    UDI: 04015630939381

    Distribution

    US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, ID, IL, IN,KS, KY, MD, ME, MO, NC, NE, NJ, NM, NY, OH, OK, SC, SD, TN, TX, VA, WA, WY.

    Quantity

    10, 489 kits