Events

Retiro De Equipo (Recall) de Device Recall Triage TOX Drug Screen (MTD) Panel

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 Alere San Diego dba Biosite Innovacon Hemosense 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
    61637
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1446-2012
  • Fecha de inicio del evento
    2010-03-12
  • Fecha de publicación del evento
    2012-04-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108600
  • 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
    Enzyme immunoassay, methadone - Product Code DJR
  • Causa
    The recall was initiated because biosite inc. received an increase in customer calls regarding unexpected positive thc results when using the triage tox drug screen.
  • Acción
    Biosite sent a "PRODUCT ADVISORY NOTICE" letter dated March 12, 2010 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter states that customers may continue to use the product. Customers were instructed to complete and fax an enclosed verification form to Technical Services at 1-858-695-7100. Customers with any questions about the information contained in the notification were instructed to contact Biosite Inc. at (888) 246-7483.

Device

Device Recall Triage TOX Drug Screen (MTD) Panel
  • Modelo / Serial
    Lot # Mfr date Qty of devices W44704BR 2/17/09 6358 W44708BR 2/24/09 5940 W44710BR 2/25/09 5285 W44715BR 312/09 6676 W44716BR 3/3/09 6076 W44721B 3/9/09 6182 W44723BCR 3/10/09 5473 W44724B 3/11/09 8263 W44728B 3116/09 8166 W44729B 3117/09 7665 W44730BR 3/18/09 8181 W44734B 3/24/09 7660 W44735BR 3/24/09 7391 W44742B 3/30/09 7386 W44745B 4/1/09 5761 W44746B 4/1/09 5476 W44748B 4/6/09 5802 W44754B 4/16/09 6635 W44755B 4/17/09 6222 W44756B 4/19/09 7767 W44761B 4/24/09 5165 W44762B 4/26/09 9623 W44763B 4/27/09 3565 W44765B 5/3/09 7232 W44766B 5/4/09 5243 W44769B 5/5/09 6333 W44770B 5/6/09 7595 W44773B 5/8/09 8480 W44774B 5/11/09 8138 W44775B 5/12/09 6890 W44776B 5/20/09 5058 W44777B 5/21109 2838 W45791B 5/21/09 7700 W45792B 5/22/09 6534 W45793B 5/25/09 8539 W45794B 5/26/09 6376 W45795B 5/27/09 6247 W45797B 5/31/09 6681 W45798B 6/1/09 1646 W45799B 6/1/09 8543 W45800B 6/2/09 8755 W45801B 6/7/09 8752 W45802B 6/8/09 7064 W45803B 6/9/09 8555 W45804B 6/10/09 5601 W45805B 6/15/09 8552 W45806B 6/16/09 8536 W45807B 6/17/09 8282 W45808B 6/17/09 8059 W45809B 6/21/09 7738 W458lOB 6/22/09 8753 W4581lB 6/23/09 8099 W45812B 6/23/09 8615 W45813B 6/24/09 8590 W45814B 6/25/09 8401 W45815B 7/8/09 8621 W45816B 7/9/09 5358 W45817B 7/10/09 7491 W45818B 7/10/09 3935 W45819B 7/12/09 8768 W45820B 7/13/09 8713 W4582lB 7/14/09 7640 W45822B 7/15/09 2487 W45823B 7/15/09 8301 W45824B 7/17/09 6603 W45825B 7/17/09 2453 W45826B 7/20/09 8040 W45827B 7/21/09 6064 W45828B 7/22/09 7913 W45829B 7/23/09 7047 W45830B 7/27/09 8510 W4583lB 7/28/09 8420 W45832B 7/28/09 8547 W45833B 7/29/09 8316 W45834B 8/2/09 8521 W45835B 8/3/09 5883 W45836B 8/5/09 5512 W45837B 8/5/09 7566 W45838B 8/10/09 8635 W45839B 8/11/09 7993 W45840B 8/13/09 8669 W45841B 8/13/09 8180 W45842B 8/17/09 8685 W45843B 8/18/09 6962 W45844B 8/18/09 8618 W45845B 8/19/09 8432 W45846B 8/20/09 7574 W45847B 8/21/09 5835 W45848B 8/24/09 8523 W45849B 8/25/09 7289 W45850B 8/26/09 7845 W45851B 8/26/09 6552 W45852B 8/27/09 7827 W45853B 8/31/09 9141 W45854B 9/1/09 8092 W45855B 9/2/09 8018 W45856B 9/3/09 6921 W45857B 9/7/09 7630 W45858B 9/8/09 6584 W45859B 9/9/09 2697 W45860B 9/15/09 8436 W45861B 9/16/09 8093 W45862B 9/17/09 8944 W45863B 9/18/09 7152 W45864B 9/21/09 8620 W45865B 9/23/09 7777 W45866B 9/24/09 8351 W45867B 9/25/09 7955 W45868B 9/28/09 8580 W45869B 9/29/09 8552 W45870B 9/30/09 7177 W45871B 9/30/09 8131 W45872B 10/5/09 7370 W45873B 10/6/09 7674 W45874B 10/7/09 8123 W45875B 10/8/09 3511 W45876B 10/12/09 8469 W45877B 10/13/09 8000 W45878B 10/14/09 5711 W45879B 10/15/09 6873 W45880B 10/15/09 6343 W45881B 10/21/09 4967 W45882B 10/21/09 3997 W45883B 10/22/09 8257 W45884B 10/23/09 6718 W45885B 10/27/09 8085 W46852B 10/28/09 1465 W46853B 10/28/09 4810 W46854B 10/29/09 7786 W46855B 11/3/09 7287 W46856B 11/4/09 7596 W46857B 11/5/09 7073 W46858B 11/6/09 5724 W46859B 11/10/09 6935 W46860B 11/11/09 7435 W46861B 11/12/09 7539 W46862B 11/12/09 8815 W46863B 11/13/09 5394 W46864B 11/16/09 5984 W46865B 11/19/09 6421 W46866B 11/22/09 6211 W46867B 11/23/09 8376 W46868B 11/30/09 9002 W46869B 12/1/09 6303 W46870B 12/7/09 5414 W46871B 12/8/09 6810 W46872B 12/9/09 8317 W46873B 12/10/09 7140 W46874B 12/10/09 7300 W46875B 12/11/09 6108 W46876B 12/13/09 7691 W46877B 12/14/09 6219 W46878B 12/15/09 7378 W46879B 12/16/09 7469 W46880B 12/17/09 8029 W4688lB 12/17/09 6741 W46882B 12/18/09 8917 W46883B 12/20/09 5584 W46884B 12/21/09 2421 W46885B 12/21/09 6073 W46886B 12/22/09 9071 W46887B 1/4/10 8272 W46888B 1/5/10 9027 W46889B 1/6/10 8835 W46890B 1/6/10 8708 W46891B 1/7110 7784 W46892B 1/11/10 7763 W46894B 1/12/10 3193 W46895B 1/12/10 3128 W46896B 1/13/10 8020 W46897B 1/14/10 8723 W46898B 1/15/10 5109 W47182B 1/17/10 6564 W47184B 1/19/10 8021 W47185B 1/19/10 7684 W47186B 1/20/10 8582 W47187B 1/21/10 7331
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Canada and European Union.
  • Descripción del producto
    Triage TOX Drug Screen (MTD) Panel, Model # 94400. || Type of Packaging: 25 individually pouched devices in a labeled kit box. || The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.
  • Manufacturer
    Alere San Diego dba Biosite Innovacon Hemosense Inc

Manufacturer

Alere San Diego dba Biosite Innovacon Hemosense Inc
  • Dirección del fabricante
    Alere San Diego dba Biosite Innovacon Hemosense Inc, 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • 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