Events

Retiro De Equipo (Recall) de ARCHITECT i1000SR" Processing Module

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 Abbott 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
    55360
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2482-2010
  • Fecha de inicio del evento
    2008-10-21
  • Fecha de publicación del evento
    2010-09-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90666
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    During manufacturing, two components of the architect i1000sr were reversed which could potentially cause falsely elevated patient results due to a sample-reagent and reagent-sample carryover.
  • Acción
    ABBOTT issued Technical Service Bulletins to Field Service Representatives who then inspected every unit .

Device

ARCHITECT i1000SR" Processing Module
  • Modelo / Serial
    Serial Numbers: (1st recall) i1SR01001-1224; 1226-1300; 1302-1306; 1308-1313; 1315-1316; 1318-1352; 1355-1363; 1365; 1376; 1381-1382  Extended to include serial numbers manufactured from 04/01/08 to 03/31/09: i1SR01021, 1026, 1032, 1040, 1036, 1043, 1059, 1065, 1069, 1071, 1071, 1074, 1082, 1094, 1106, 1107, 1109, 1111, 1112, 1114, 1117, 1119, 1121, 1123, 1128, 1133, 1135, 1138, 1139, 1158, 1162, 1167, 1171, 1173, 1177, 1183, 1186, 1188, 1189, 1198, 1200, 1201, 1205, 1209, 1211, 1217, 1225, 1230, 1243, 1246, 1249, 1250, 1260, 1262, 1272, 1277, 1279, 1284, 1286-1288, 1290, 1294, 1301, 1304, 1312, 1317, 1321, 1324-1327, 1332-1335, 1338, 1339, 1342-1345, 1347, 1348, 1351-1356, 1363-1368, 1370-1372, 1375, 1377-1387, 1389-1396, 1398-1410, 1412-1414, 1416-1441, 1443-1530, 1532-1536 (some of these #'s were removed whose field status was Demo/Training and instruments that had TSB 117-004 completed prior to Feb 19.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution:USA including states of: CO, DC, FL, GA, IL, LA, MA, MN, NY, OH, OK, TX, UT, and WV and countries including: Australia, Brazil, Bogota, Canada, China WFOTC, Columbia, Curacao (NETH ANT), Germany, Hong Kong, Japan, Mexico, Singapore, and Taiwan.
  • Descripción del producto
    ARCHITECT¿ i1000SR" Processing Module System For In Vitro Diagnostic Use, Abbott Laboratories Abbott Park, IL || Product List Number, Part # or Model: 01L86-01 || In Vitro Diagnostic use only. The Abbott ARCHITECT System is designed to perform automated: Chemistry tests, utilizing photometry and potentiometric technology, and Immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.
  • Manufacturer
    Abbott Laboratories, Inc

Manufacturer

Abbott Laboratories, Inc
  • Dirección del fabricante
    Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 152020, Irving TX 75038-4313
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA