Device Recall Tecan

  • Model / Serial
    Serial numbers 5583, 5606, 6372, 6394, 6396, 6398, 6558, 7210, 7574, 7595 and 7615.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide. California, Connecticut, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin.
  • Product Description
    Tecan clinical workstation; Tecan Genesis 150 back end, Roche catalog number 03585352001.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Source
    USFDA

7 devices with a similar name

Learn more about the data here

  • Model / Serial
    Instrument Material #30050303, PC Serial numbers: CND5219H0B, Instrument Serial #1208002673; PC Serial numbers: CND44273RW, Instrument Serial #1211001074; PC Serial numbers: CND44273SC, Instrument Serial #1309006773; PC Serial numbers: 2CE3461RNR, Instrument Serial #1311008588; PC Serial numbers: 2CE33625KT, Instrument Serial #1401006356; PC Serial numbers: 2CE33626Q9, Instrument Serial #1403000833; PC Serial numbers: 2CE3461RR3, Instrument Serial #1403003928; PC Serial numbers: 2CE33625M4, Instrument Serial #1403005482; PC Serial numbers: 2CE41503JF, Instrument Serial #1405000420; PC Serial numbers: CND5219H4R, Instrument Serial #1405002510; PC Serial numbers: 2CE42406YJ, Instrument Serial #1406009472; PC Serial numbers: 2CE4220LGP, Instrument Serial #1410002321; PC Serial numbers: 2CE424072G, Instrument Serial #1410004940; PC Serial numbers: 2CE4240DJ7, Instrument Serial #1411008631; PC Serial numbers: 2CE424071M, Instrument Serial #1412005274; PC Serial numbers: CND44273XR, Instrument Serial #1503001536; PC Serial numbers: CND5219H1S, Instrument Serial #1503002986; PC Serial numbers: CND44262KJ, Instrument Serial #1503004890; PC Serial numbers: CND442625D, Instrument Serial #1501008506; PC Serial numbers: CND442627J, Instrument Serial #1501008513; PC Serial numbers: CND44273SB, Instrument Serial #1505009092; PC Serial numbers: CND442626B, Instrument Serial #1509001022; PC Serial numbers: CND5219H11, Instrument Serial #1509008146; PC Serial numbers: CND5219H6D, Instrument Serial #1511009716; PC Serial numbers: 2CE3461RSX, Instrument Serial #1512005211; PC Serial numbers: 2CE3381HT1, Instrument Serial #1601005141 and PC Serial numbers: CND5219H2K, Instrument Serial #1510004918.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product Description
    Tecan Infinite 200. || The SUNRISE 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.
  • Manufacturer
  • Model / Serial
    Instrument Material #30034301, PC Serial number: 2CE33625NS, Instrument Serial #1508007738.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product Description
    Tecan Infinite M1000 || The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the Infinite M1000 allows the measurement of fluorescence polarization and luminescence. The Infinite M1000 is also robotic compatible and offers a built-in stacker option as well as an external injector module. The Infinite M1000 is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANSI/SBS standards
  • Manufacturer
  • Model / Serial
    Instrument Material #30063849, PC Serial # 2CE3362609, Instrument Serial #1110008219; PC Serial # CND5219H33, Instrument Serial #1204007588; PC Serial # 2CE3462FTJ, Instrument Serial #1301009861; PC Serial # 2CE3462FTD, Instrument Serial #1311007574; PC Serial #2CE33625KP, Instrument Serial #1404000703; PC Serial #2CE33625ND, Instrument Serial #1404000704; PC Serial #2CE41503PY, Instrument Serial #1406000407; PC Serial #2CE41503NW, Instrument Serial #1408001415; PC Serial #2CE41503K0, Instrument Serial #1407003406; PC Serial #CND5219GY7, Instrument Serial #1509001006 and PC Serial #CND44273YB, Instrument Serial #1604003735.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product Description
    Tecan Infinite M1000 PRO || The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity measurements, the Infinite M1000 PRO can also perform fluorescence polarization and luminescence measurements (including luminescence scans) as well as Amplified Luminescent Proximity Homogeneous Assays (AlphaScreen and AlphaLISA). The Infinite M1000 PRO is also robotic compatible and offers a built-in stacker option as well as an external injector module. The Infinite M1000 PRO is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANSI/SBS standards.
  • Manufacturer
  • Model / Serial
    Genesis 100, 150 &200, Tecan PosID2 units with firmware version 2.5 or lower
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Instruments requiring upgrade were distributed to various clinical laboratories and blood banks Nationwide and World wide .
  • Product Description
    Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower.
  • Manufacturer
  • Model / Serial
    Serial numbers 5524, 6177, 6224, 6376, 6393, 6395, 6397, 6557, 7150, 7349, 7350, 7594, 7616 and 7724.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide. California, Connecticut, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin.
  • Product Description
    Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001.
  • Manufacturer
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