Events

Retiro De Equipo (Recall) de Device Recall HemosIL PTFibrinogen HS PLUS

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 Instrumentation Laboratory Co..

¿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
    69824
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0832-2015
  • Fecha de inicio del evento
    2014-11-21
  • Fecha de publicación del evento
    2014-12-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131733
  • 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
    Test, time, prothrombin - Product Code GJS
  • Causa
    Some vials of hemosil pt-fibrinogen hs plus, part no. 0008469810 (various lots manufactured prior to june 2014) exhibit a yellow/brownish color after reconstitution (yellow color or darker) instead of the typical white to off-white color. vials exhibiting this yellow/brownish color were observed to cause prolonged prothrombin (pt) clotting times.
  • Acción
    The firm, Instrumentation Laboratory, sent an "URGENT MEDICAL DEVICE CORRECTION" letter (dated 11/21/2014) to US and Canadian customers via USPS on 11/21/2014 for all in-date lots of HemosiL PT-Fibrinogen HS PLUS, Part No. 0008469810, manufactured prior to June 2014. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: if they observe any yellow/brownish color after reconstitution, they are not to use the affected vial; discard the vial and reconstitute another vial; only use a vial if the reconstituted color is the typical white to off-white color; run quality controls at least once every 8 hour shift in accordance with GLP and insert instruction sheet; share this information with your laboratory staff and follow initial procedures; forward this notification to all affected locations within your facility; retain a copy of this notification for your records and complete and return the tracking record form within 10 business days of receiving notification even if you do not use these reagents via fax at 781-861-4207 or email to: ra-usa@ilww.com. On 11/21/2014, e-mail notifications were sent to the IL/Werfen Country Affiliates and International Group (who manage the local country dealers and distributors) to prepare and issue Field Safety Notices in the respective languages to their customers. For technical questions, please contact the IL Technical Support Center at 1-800-678-0710, Option # 2 (ACL Coagulation Products). For additional questions, please contact your IL Customer Service Representative at 1-800-955-9525, Option # 2.

Device

Device Recall HemosIL PTFibrinogen HS PLUS
  • Modelo / Serial
    Lots: N1122175, exp. date 11/30/2014;  N0132936, exp. date 1/31/2015; N0233302, exp. date 2/28/2015; N0333382, exp. date 3/31/2015; E0333382, exp. date 3/31/2015; N0333626, exp. date 3/31/2015; N0433932, exp. date 4/30/2015; N0634953, exp. date 6/30/2015; N0735317, exp. date 5/31/2015; N0735599, exp. date 7/31/ 2015; N0836106, exp. date 8/31/2015; N0936197, exp. date 9/30/2015;  N0349325, exp. date 12/31/2015; N1222324, exp. date 12/31/2015; N0148094, exp. date 12/31/2015;  N0248652, exp. date 2/29/2016; N0249017, exp. date 2/29/2016;  N0449790, exp. date 4/30/2016; N0440009, exp. date 4/30/2016.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) including Puerto Rico; and countries of: ALBANIA, ALGERIA, ANDORRA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BELARUS, BRAZIL, BRUNEI, BULGARIA, CHILE, CHINA, COLUMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, FRANCE, GABON, GEORGIA, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, KENYA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, NEW ZEALAND, PAKISTAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, TURKEY, UAE, UGANDA, UKRAINE, UNITED KINGDOM, AND URUGUAY.
  • Descripción del producto
    HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. || A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
  • Manufacturer
    Instrumentation Laboratory Co.

Manufacturer

Instrumentation Laboratory Co.
  • Dirección del fabricante
    Instrumentation Laboratory Co., 180 Hartwell Road, Bedford MA 01730-2443
  • Empresa matriz del fabricante (2017)
    Werfenlife Sa.
  • Source
    USFDA