Events

Rappel de CLAY ADAMS Dynac III Centrifuge

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 Becton Dickinson & Co..

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
    54076
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1069-2010
  • Date de mise en oeuvre de l'événement
    2009-08-17
  • Date de publication de l'événement
    2010-03-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-04-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87369
  • 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
    Cenrifuges (micro, ultra, refrigerated) for clinical use - Product Code JQC
  • Cause
    Medical laboratory centrifuge component may have been assembled incorrectly and cause disabling of the safety feature which prevents customers from opening the centrifuge while it is spinning.
  • Action
    An "Urgent Product Recall" letter dated August 2009 was sent to the customers. The letter described the affected product, problem and the action to be taken by customers. The customers were advised to discontinue use of the centrifuge for repair or replacement with refurbished unit , provide an Excel file or a list with name, address and telephone number of end-users who were shipped this product from their distribution branches so that BD may inform them of the issue,and return the enclosed response form. For further assistance regarding product replacement and returns contact our Technical Services Department at 1-800-638-8663.

Device

CLAY ADAMS Dynac III Centrifuge
  • Modèle / numéro de série
    Serial Number: 4510001, 4510002, 4510003, 4510004, 4510005, 4510006, 4510007, 4510008, 4510009, 4510010, 4510011, 4510012, 4510013, 4510014, 4510015, 4510016, 4510017, 4510018, 4510019, 4510020, 4510021, 4510022, 4510023, 4510024, 4510025, 4510026, 4510027, 4510028, 4510029, 4510030, 4510031, 4510032, 4510033, 4510034, 4510035, 4510036, 4510037, 4510038, 4510039, 4510040, 4510041, 4510042, 4510043, 4510044, 4510045, 4510046, 4510047, 4510048, 4510049, 4510050, 4510051, 4510052, 4510053, 4510054, 4510055, 4510056, 4510057, 4510058, 4510059, 4510060, 4510061, 4510062, 4510063, 4510064, 4510065, 4510066, 4510067, 4510068, 4510069, 4510070, 4510071, 4510072, 4510073, 4510074, 4510075, 4510076, 4510077, 4510078, 4510079, 4510080, 4510081, 4510082, 4510083, 4510084, 4510085, 4510086, 4510087, 4510088, 4510089, 4510090, 4510091, 4510092, 4510093, 4510094, 4510095, 4510096, 4510097, 4510098, 4510099, 4510100, 4510101, 4510102, 4510103, 4510104, 4510105, 4510106, 4510107, 4510108, 4510109, 4510110, 4510111, 4510112, 4510113, 4510114, 4510115, 4510116, 4510117, 4510118, 4510119, 4510120, 4520001, 4520002, 4520003, 4520004, 4520005, 4520006, 4520007, 4520008, 4520009, 4520010, 4520011, 4520012, 4520013, 4520014, 4520015, 4520016, 4530001, 4530002, 4530003, 4530004, 4530005, 4530006, 4530007, 4530008, 4530009, 4530010, 4530011, 4530012, 4530013, 4530014, 4530015, 4530016, 4530017, 4530018, 4530019, 4530020, 4540001, 4540002, 4540003, 4540004, 4540005, 4540006, 4540007, 4540008, 4540009, 4540010, 4540011, 4540012, 4540013, 4540014, 4540015, 4540016, 4540017, 4540018, 4540019, 4540020, 4540021, 4540022, 4540023, 4540024, 4540025, 4540026, 4540027, 4540028, 4540029, 4540030, 4540031, 4540032, 4540033, 4540034, 4540035, 4540036, 4540037, 4540038, 4540039, 4540040, 4540041, 4540042, 4540043, 4540044, 4540045, 4540046, 4540047, 4540048, 4540049, 4540050, 4540051, 4540052, 4540053, 4540054, 4540055, 4540056, 4540057, 4540058, 4540059, 4540060, 4540061, 4540062, 4540063, 4540064, 4540065, 4540066, 4540067, 4540068, 4540069, 4540070, 4540071, 4540072, 4540073, 4540074, 4550001, 4550002, 4550003, 4550004, 4550005, 4550006, 4550007, 4550008, 4550009, 4550010, 4550011, 4550012, 4550013, 4550014, 4550015, 4550016, 4560001, 4560002, 4560003, 4560004, 4560005, 4560006, 4560007, 4560008, 4560009, 4560010, 4560011, 4560012, 4560013, 4560014, 4560015, 4560016, 4570001, 4570002, 4570003, 4570004, 4570005, 4570006, 4570007, 4570008, 4570009, 4570010, 4570011, 4570012, 4570013, 4570014, 4570015, 4570016, 4570017, 4570018, 4570019, 4570020, 4570021, 4570022, 4570023, 4570024, 4570025, 4570026, 4570027, 4570028, 4570029, 4570030, 4570031, 4570032, 4570033, 4570034, 4570035, 4570036, 4570037, 4570038, 4570039, 4570040, 4570041, 4570042, 4570043, 4570044, 4570045, 4570046, 4570047, 4570048, 4580001, 4580002, 4580003, 4580004, 4580005, 4580006, 4580007, 4580008, 4580009, 4580010, 4580011, 4580012, 4580013, 4580014, 4580015, 4580016, 4580017, 4580018, 4580019, 4580020, 4580021, 4580022, 4580023, 4580024, 4580025, 4580026, 4580027, 4580028, 4580029, 4580030, 4580031, 4580032, 4590001, 4590002, 4590003, 4590004, 4590005, 4590006, 4590007, 4590008, 4590009, 4590010, 4590011, 4590012, 4590013, 4590014, 4590015, 4590016, 4590017, 4590018, 4590019, 4590020, 4590021, 4590022, 4590023, 4590024, 4590025, 4590026, 4590027, 4590028, 4590029, 4590030, 4590031, 4590032, 4590033, 4590034, 4590035, 4590036, 4590037, 4590038, 4590039, 4590040, 4600001, 4600002, 4600003, 4600004, 4600005, 4600006, 4600007, 4600008, 4600009, 4600010, 4600011, 4600012, 4600013, 4600014, 4600015, 4600016, 4600017, 4600018, 4600019, 4600020, 4600021, 4600022, 4600023, 4600024, 4610001, 4610002, 4610005, 4610006, 4610008
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and Mexico, Phillipines, Columbia, Chile, Ecuador, Venezuela, Puerto Rico, Canada and Singapore.
  • Description du dispositif
    CLAY ADAMS¿ Dynac¿ III Centrifuge, 120V, Model Number 420104 || DYNAC III is a multi-purpose centrifuge, designed for clinical laboratories performing separations in hematology, chemistry, urinalysis, blood banking, microbiology and cytology.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Adresse du fabricant
    Becton Dickinson & Co., 7 Loveton Cir, Sparks MD 21152-9212
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA