Events

Rappel de Device Recall Alere Triage TOX Drug Screen 9 Panel

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Alere San Diego, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    63091
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2460-2012
  • Date de mise en oeuvre de l'événement
    2012-07-12
  • Date de publication de l'événement
    2012-09-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-02-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112528
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Colorimetry, acetaminophen - Product Code LDP
  • Cause
    Alere san diego is recalling alere triage tox drug screen because there is a possibility that after installing the code chip provided with the affected lots: amp, bar, and pcp, the threshold ranges may not be consistently set correctly in all meters.
  • Action
    Alere sent a 'NOTICE OF CORRECTION" letter dated July 12, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers with questions were instructed to contact Technical Services at (877) 308-8287. Customers were instructed to complete the Customer/Distributor Verification Form Notice of Correction even if they do not have any involved product and fax back to Technical Services at (858) 805-8457 or scan and email to responses.ts@alere.com.

Device

Device Recall Alere Triage TOX Drug Screen 9 Panel
  • Modèle / numéro de série
    Lot Codes: K51245RB, W51022RB, W51207RB
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. || The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere Triage Meters for the 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, 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, Inc.

Manufacturer

Alere San Diego, Inc.
  • Adresse du fabricant
    Alere San Diego, Inc., 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “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