BEUDAMED
    FDA Enforcement Class II Terminated

    Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068

    Recall: Z-0052-2021 · Reported October 14, 2020

    Enforcement

    Recall Number
    Z-0052-2021
    Event ID
    86374
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 14, 2020
    Initiation Date
    August 19, 2020
    Classification Date
    October 2, 2020
    Termination Date
    August 25, 2023
    Address
    500 Gbc Dr, N/A, Newark, DE, 19702-2466, United States

    Description

    Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068

    Reason

    Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. The average bias observed for patient samples using lots EB0255 and EA0178 of the Dimension EXL Troponin compared with a control lot was +25%. A maximum bias of +34% in patient samples around the 99th percentile observed

    Code Info

    Lot # EB0255 UDI: 00842768037726EB025520091110471068840

    Distribution

    US Nationwide distribution.

    Quantity

    533 US and 1822 OUS