Events

Rappel de Device Recall Cardiac Marker Test

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
    67910
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1540-2014
  • Date de mise en oeuvre de l'événement
    2014-03-20
  • Date de publication de l'événement
    2014-05-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-01-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126592
  • 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
    Test, natriuretic peptide - Product Code NBC
  • Cause
    These lots may not recover within range when tested using certain commercially available controls.
  • Action
    Alere San Diego, Inc. initiated this recall by sending out notification letters via email and/or regular mail on March 20, 2014. The letter titled "URGENT MEDICAL DEVICE CORRECTION", dated "March 20, 2014, informed customers of the reason for recall, and potential impact, product description with lots numbers, customer/distributor required action, and contact information. The letter was accompanied by a "Customer/Distributor Verification Form". Customers were instructed that they may continue to use reagent lots 329599 and 331265. " If they are using an alternate commercial control with Reagent Pack Lots 329599 or 331265, they can receive the Alere Triage¿ BNP QC Controls PN 98201 by requesting them on the Verification Form. "Customers were instructed to share this information with their laboratory staff, including their laboratorys medical director and retain this notification as part of their laboratory Quality System documentation. For questions regarding this recall call 858-805-2000, ext 3015. " If they have forwarded the product listed above to another laboratory, please provide a copy of this letter to them. " Complete and FAX the enclosed Verification Form within 10 days to confirm your receipt of this notice. Only one Verification Form is required per facility. Customers with questions were instructed to call 877-308-8287 or email Triage.Support@alere.com.

Device

Device Recall Cardiac Marker Test
  • Modèle / numéro de série
    Model Number: 98200. Lot/Unit Codes: Lot #329599, K329599 (Distributed OUS), 331265 and K331265 (Distributed OUS).  Expiration date, or Expected shelf life: 10/31/14 and 12/31/14
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, EU, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan and United Arab Emirates.
  • Description du dispositif
    Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage BNP test is intended to be used as an aid in the diagnosis of congestive heart failure (heart failure), as an aid in the assessment of severity of congestive heart failure, for the risk stratification of patients with acute coronary syndromes, and for the risk stratification of patients with heart failure.
  • 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