Events

Rappel de Alere Triage Total 5 Control Level 1

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
    75443
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0588-2017
  • Date de mise en oeuvre de l'événement
    2016-10-12
  • Date de publication de l'événement
    2016-11-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-07-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150328
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • Cause
    Encoded with incorrect ranges that are not consistent with the ranges printed on the expected value card.
  • Action
    The firm, Alere, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 10/2016 to customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of and discard the CODE Chip contained within the Alere Triage Total 5 Control Level 1 PN 88753 Lot C3233A; install the replacement QC Sample CODE Chip for Lot C3233AR; share this information with your laboratory staff and retain this notification as part of your laboratory QS documentation; if you have forwarded the product to another laboratory, provide copy of this notification; and complete and return the Customer/Distributor Verification Form via Fax to Alere Technical Services at +1 858 805 8457 within 10 business days. Customer with any questions about the information contained in the notification are instructed to contact: Alere San Diego, Inc. 9975 Summers Ridge Road San Diego, CA 92121, U.S.A. Phone: 844-320-5124 FAX: 858-805-8457 E-mail: Responses.ts@alere.com On 11/10/16 a revised Urgent Medical Device Correction letter was sent to their customers to inform them of the recall.

Device

Alere Triage Total 5 Control Level 1
  • Modèle / numéro de série
    C3233A
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Alere Triage Total 5 Control Level 1, Model No. 88753 || Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate the Triage tests. The results of quality control testing do not impact direct patient care and should not influence clinical decision making process the physician uses to make clinical diagnosis for the patient. Indications for || Use: The Alere Triage Total 5 Controls are assayed materials to be used with the Alere Triage Cardiac Panel, Alere Triage CardioProfiler Panel, Alere Triage Profiler SOB Panel, Alere Triage BNP Test, Alere Triage D-Dimer Test, and Alere Triage Meters to assist the laboratory in monitoring test performance.
  • 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