Events

Rappel de Device Recall Infinite M1000 PRO

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Tecan US, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    71352
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1968-2015
  • Date de mise en oeuvre de l'événement
    2015-05-29
  • Date de publication de l'événement
    2015-07-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137389
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Fluorometer, for clinical use - Product Code KHO
  • Cause
    A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
  • Action
    Tecan sent an Urgent Field Corrective Action letter dated May 29, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached Customer Response Form. For questions contact your local Tecan Helpdesk.

Device

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.

Manufacturer

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