Events

Retiro De Equipo (Recall) de Device Recall Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K Assay

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Sekisui Diagnostics P.E.I. Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    73129
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1171-2016
  • Fecha de inicio del evento
    2016-01-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143121
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Colorimetry, acetaminophen - Product Code LDP
  • Causa
    Crystal formation in the color reagent (r2) when left on board automated analyzers causing samples to under recover.
  • Acción
    Sekisui sent an Important Field Correction - Customer Notification letter dated January 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Discard all reagent in house with a current expiration date of 2016-09. 2. Update the expiration on all remaining kits on hand with the new expiration dates provided 3. When adding additional reagent to the analyzer, a new reagent wedge should be used. 4. If crystals are observed within reagent stored on-board, reagent should be discarded and replaced with fresh reagent. 5. Complete, sign and return the attached CONFIRMATION OF NOTIFICATION form by FAX to the number provided. This will indicate receipt of this Field Correction, act as confirm action of compliance with the actions,and allow for issuance of replacement material for expired product on hand (lots 47677, 47694, 47695). Questions contact Technical Services at 1-800-565-0265 or via email at PEIDiagnosticTechnical@sekisui-dx.com

Device

Device Recall Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K Assay
  • Modelo / Serial
    Catalog Number: 506-10 Lot Codes 47677 47694 47649 47650 47662 47663 48253 48385 48386 Catalog Number: 506-30 Lot Codes: 47695 48294
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, IA, ID, IL, MA, , MN, MT and ND., and to the countries of Canada, France and Hong Kong.
  • Descripción del producto
    Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic || Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml || Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml || In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.
  • Manufacturer
    Sekisui Diagnostics P.E.I. Inc.

Manufacturer

Sekisui Diagnostics P.E.I. Inc.
  • Dirección del fabricante
    Sekisui Diagnostics P.E.I. Inc., 70 Watts Ave, Charlottetown Canada
  • Empresa matriz del fabricante (2017)
    Sekisui Chemical Co. Ltd.
  • Source
    USFDA