BEUDAMED
    FDA Enforcement Class II Terminated

    Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).

    Recall: Z-1311-2018 · Reported April 11, 2018

    Enforcement

    Recall Number
    Z-1311-2018
    Event ID
    79462
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 11, 2018
    Initiation Date
    December 22, 2017
    Classification Date
    April 4, 2018
    Termination Date
    April 5, 2019
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).

    Reason

    Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers.

    Code Info

    Elecsys BRAHMS PCT: 07301715190 Lot number 204084

    Distribution

    US Distribution in states of: CA, FL and IN.

    Quantity

    47