BEUDAMED
    FDA Enforcement Class II Terminated

    SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics

    Recall: Z-2661-2016 · Reported August 31, 2016

    Enforcement

    Recall Number
    Z-2661-2016
    Event ID
    74806
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tecan US, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2016
    Initiation Date
    July 25, 2016
    Classification Date
    August 25, 2016
    Termination Date
    January 23, 2017
    Address
    9401 Globe Center Drive, Suite 140, Morrisville, NC, 27560, United States

    Description

    SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics

    Reason

    The batteries have the potential to overheating, melt or char.

    Code Info

    Instrument Material #16039400, PC Serial # 2CE4220L6Z, Instrument Serial # 1201008596 and Instrument Material #30087502, PC Serial #2CE3362777, Instrument Serial #1403008116; PC Serial #2CE3461RV1, Instrument Serial #1404001455; PC Serial #2CE3461RVY, Instrument Serial #1404001456; PC Serial #2CE41503MD, Instrument Serial #1405003467; PC Serial #2CE3462FX0, Instrument Serial #1405002373; PC Serial #2CE4220BW9, Instrument Serial #1407000866; PC Serial #2CE42406XP, Instrument Serial #1409007597; PC Serial #CND4426259, Instrument Serial #1412005606; PC Serial #CND442618S, Instrument Serial #1503003902; PC Serial #CND44261R2, Instrument Serial #1504007122; PC Serial #CND44273XJ, Instrument Serial #1504004857; PC Serial #CND5219GYY, Instrument Serial #1506006286; PC Serial #CND5219GYX, Instrument Serial #1509005071; PC Serial #CND5219H21, Instrument Serial #1511009478; PC Serial #CND5219GYN, Instrument Serial #1512005969; PC Serial #CND5219H68, Instrument Serial #1603000018; PC Serial #CND5219GYJ, Instrument Serial #1606001277 and PC Serial #CND5219GZW, Instrument Serial #1606001263.

    Distribution

    Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.

    Quantity

    19 units