Events

Retiro De Equipo (Recall) de VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests,

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 Bio-Rad Laboratories, 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
    59868
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0021-2012
  • Fecha de inicio del evento
    2011-09-12
  • Fecha de publicación del evento
    2011-10-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103908
  • 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
    Assay, glycoslylated hemoglobin - Product Code LCP
  • Causa
    A previous recall related to reports of calibration failure and late retention times using elution buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
  • Acción
    Bio-Rad sent an Urgent Medical Device Correction letter on September 12, 2011, to all affected subsidiaries and customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discard all affected product in accordance with all local, state and federal disposal procedures. If customers distributed the product further they should direct their customers to discard all unused product. Customers were asked to please translate (if necessary) the attached "Customer Medical Device Correction Response Form," customers should add their local contact information and distribute to all affected customers in their region by mail or fax. Compile tracking documentation (e.g. Excel spreadsheet) for all customers who received the Medical Device Correction Letter. Complete the "SUBSIDIARY MEDICAL DEVICE CORRECTION RESPONSE FORM" and fax to Bio-Rad Regulatory Affairs at (510) 741-3954, or e-mail PDF to CSD_RA/Hercules/US/BIO-RAD. Customers would be issued credits for the affected products based on their request. For questions call (510) 741-3954.

Device

VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests,
  • Modelo / Serial
    Model number: 270-2415; Lot number 70211066, expiry 03/31/2012; Lot number 70211068, expiry 3/31/2012. Contains Buffer lot number: AA10758/AA10759, expiry 3/31/12.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and to New Zealand, Canada, France, England, China, India, Mexico, Italy, Brazil, Australia, Singapore, Thailand, SriLanka, hong Kong, Sweden, Germany, Peru, Jamaica, Uruguay, Columbia, Argentina, Chile, Paraguay and Korea.
  • Descripción del producto
    VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests, || IVD, Made in United States. || Kit contains: || 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer || 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer || 3. Cartridge Set, 2 cation exchange analytical cartridges, 5 cation exchange Guard cartridges. || 4. CD-ROM 1 - CD Rom with program parameters || 5. Calibration/Diluent set - 2 levels, 3 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. || 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, || 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. || 8. Instruction Manual. || Bio-Rad Laboratories, Hercules, CA 94547. || Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
  • Manufacturer
    Bio-Rad Laboratories, Inc.

Manufacturer

Bio-Rad Laboratories, Inc.
  • Dirección del fabricante
    Bio-Rad Laboratories, Inc., 4000 Alfred Nobel Drive, Hercules CA 94547-1803
  • Empresa matriz del fabricante (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA