Events

Retiro De Equipo (Recall) de Device Recall N PROT CONTROL SL/L, SL/M, SL/H

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 CSL Behring GmbH.

¿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
    77515
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0191-2018
  • Fecha de inicio del evento
    2017-06-05
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156196
  • 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
    Immunochemical, ceruloplasmin - Product Code CHN
  • Causa
    Siemens healthcare diagnostics has confirmed a negative bias of approximately -20% for results obtained with n antiserum to human ceruloplasmin when calibrating ceruloplasmin with various lots of n protein standard sl. n/t protein controls sl for ceruloplasmin are similarly biased. --- the affected standards and controls for the affected lots were incorrectly value assigned, which led to a lower result compared to correctly assigned standards. note: n antiserum to human ceruloplasmin (ref ouie) works as intended. --- siemens investigation indicated that n protein standard sl and corresponding n/t protein control sl (levels low, mid and high) are inaccurately assigned for ceruloplasmin.
  • Acción
    URGENT MEDICAL DEVICE CORRECTION Letter (PP17-011.a.US, dated May 30, 2017) was sent to US consignees via FedEx on 6/5/2017. URGENT FIELD CORRECTIVE ACTION Letter was e-mailed to customers Outside the US. Customers are instructed to use the re-assigned Ceruloplasmin values for the lots indicated in the letter.

Device

Device Recall N PROT CONTROL SL/L, SL/M, SL/H
  • Modelo / Serial
    SMN 10446079: Lot (UDI): 084647A (00842768016127084647A20170913), 084647C (00842768016127084647C20170913) exp. date 2017-09-13; 084648(0084276801612708464820180430),  084648C (00842768016127084648C20180430),  084648H (00842768016127084648H20180430), exp. date 2018-04-30. --- SMN 10446085: Lot (UDI): 084749D (00842768016134084749D20170917) exp. date 2017-09-17; 084750 (03 0084276801613408475020180203),  084750B (00842768016134084750B20180203), 084750E (00842768016134084750E20180203) exp. date 2018-02-03. --- SMN 10446089: Lot (UDI) 084847A (00842768016110084847A20170613),  084847B (00842768016110084847B20170613) exp. date 2017-06-13; 084848A (00842768016110084848A20171217),  084848D (00842768016110084848D20171217),  084848E (00842768016110084848E20171217),  084848H (00842768016110084848H20171217),  084848L (00842768016110084848L20171217) exp. date 2017-12-17;  084849 (0084276801611008484920180704),  084849C (00842768016110084849C20180704), 084849D (00842768016110084849D20180704) 084849E (00842768016110084849E20180704) exp. date 2018-07-04.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide including the countries of United States, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia-Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Great Britain, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, japan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Mexico, Morocco, Netherlands, New Zealand, Norway, Poland, Portugal, Republic of Korea (S), Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, South Africa, Switzerland, Syria, Taiwan, Thailand, Trinidad-Tobago, Turkey, Turkmenistan, United Arab Emirates, Uruguay, Vatican, Venezuela,
  • Descripción del producto
    SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 10446085 (Mid); N/T Protein Control SL/H, REF/Product Code OQIP19, SMN 10446089 (High);
  • Manufacturer
    CSL Behring GmbH

Manufacturer

CSL Behring GmbH
  • Dirección del fabricante
    CSL Behring GmbH, Emil-von-Behring-Str. 76, Marburg Germany
  • Empresa matriz del fabricante (2017)
    CSL Limited
  • Source
    USFDA