Devices

Device Recall Infinite M1000

  • Modèle / numéro de série
    Material Number 30034301 and 30061442.  Serial numbers 904004848 807001164 1003005106 808056058 1006007069 1108006370 906001927 811005550 1002002705 1007007321 1110004989 1009005297 910008892 1005008056 1103008195 1009003991 912003102 1007005488 912003960 1008001833 808052054 1005002244 1103001072 909005818 1005008057 1010005921 1004003572 1103008191 1001006206 809004189 907004270 1006007071 1010001688 1010001689 1110004987 1112000054 1107006152 1103008189 902000004 810003913 908006454 1002002702 912003958 1009002602 1007003513 1001007642 1110006961 911008985 908001687 1011003332 909007802 901005834 901005835 1009007093 906000659 812003360 1110004988 1009002603 1001006205 1003005108 1005008055 1112000053 1001001581 1005008053 1003000532 909000550 911000226 910004186 1009003980 1110006962 907000033 907000720 908004917 1001007641 910008890 808052053 808054758 901005836 911006512 1002002703 1003005107 1106008462 912000502 1010005918 909000551 807003935 807003936 907004267 1007007320
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, including DC
  • Description du dispositif
    Infinite M1000 in vitro diagnostic. || Product Usage: || 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 a external injector module. The Infinite M1000 is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANS/SBS standards.
  • Manufacturer
    Tecan US, Inc.
  • 1 Event

Fabricant

Tecan US, Inc.
  • Adresse du fabricant
    Tecan US, Inc., 9401 Globe Center Drive, Suite 140, Morrisville NC 27560
  • Société-mère du fabricant (2017)
    Tecan Group AG
  • Source
    USFDA

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Device Recall Infinite M1000 PRO
  • Modèle / numéro de série
    Material Number 30063849.  Serial numbers 1304002505 1211001152 1404000702 1411000822 1401004105 1205001934 1308000225 1309006882 1208001184 1204007588 1310005809 1402004302 1211001148 1305006435 1201003163 1404003953 1406001800 1403005820 1402003587 1311007574 1312002863 1406000407 1406004487 1408007771 1310007970 1201003165 1110002126 1203007860 1309000153 1408007772 1502004994 1410008825 1407000743 1406004488 1201007987 1206005852 1406008272 1410008826 1412004769 1404006185 1212002553 1403008861 1309000008 1211004372 1403000810 1208009323 1211001150 1201003164 1204006296 1407000079 1203002067 1206003111 1304004516 1309000007 1302004940 1309000154 1403000809 1212005340 1309000155 1410000939 1310003905 1409008197 1202003111 1303004426 1112005380 1303003793 1403005819 1407000077 1301009861 1503001027 1304008256 1303003794 1304002504 1309008394 1309008392 1208001186 1110002128 1503001025 1312005136 1310003908 1402005998 1309000157 1403008862 1406001502 1406008274 1406008275 1110002125 1207004756 1303003789 1205004103 1310000091 1406005776 1410011653 1211011467 1308001821 1501009602 1501001058 1307003628 1210001739 1305002229 1406006675 1211004368 1209006283 1407003406 1311001092 1406008273 1408001415 1209006284 1204000890 1211004370 1401006398 1402004300 1309005472 1310009816 1109005812 1312002864 1406006678 1301003417 1407003173 1211004364 1401000518 1401000539 1209001065 1208003232 1307001804 1403005818 1311007569 1208003233 1211004369 1409008196 1203005897 1307006629 1212002550 1403003962 1310003902 1206003110 1307001806 1202008407 1205002706 1209000238
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, including DC
  • Description du dispositif
    Infinite M1000 PRO in vitro diagnostic. || Product Usage: || 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 a external injector module. The Infinite M1000 PRO is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANS/SBS standards.
  • Manufacturer
    Tecan US, Inc.