BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1595-2021 · Initiated April 7, 2021

    Recall

    Recall Number
    Z-1595-2021
    Event Number
    87705
    Firm
    Roche Diagnostics Operations, Inc.
    FEI Number
    1823260
    Product Code
    MMI
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    April 7, 2021
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    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.

    Action

    On 04/07/2021, Roche issued Urgent Medical Device Correction via fax notifying customers that 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 was measured immediately before the Troponin I analyte on the same module, a decreased recovery of Troponin I was observed.

    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