Events

Rappel de Device Recall ARCHITECT CPeptide Reagent Kit

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 Abbott Laboratories.

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
    59335
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3031-2011
  • Date de mise en oeuvre de l'événement
    2011-07-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102319
  • 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
    Radioimmunoassay, c-peptides of proinsulin - Product Code JKD
  • Cause
    C-peptide lots 03610k000 and 01711a000 have the potential to generate falsely elevated results with certain patient samples and with non-abbott controls.
  • Action
    Abbott Laboratories sent a "PRODUCT RECALL" letter dated July 11, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the lots and destroy any remaining inventory of the lots according to laboratory procedures. A Customer Reply form was provided to customers to complete and return via fax at 1-800-777-0051. Customers can contact Abbott Customer Service at 1-877-4ABBOTT for questions regarding this notice.

Device

Device Recall ARCHITECT CPeptide Reagent Kit
  • Modèle / numéro de série
    list 3L53-25, lot numbers 03610K000 exp. 10/26/2011;  01711A000 exp. 12/12/2011; 00110L000 exp. 10/29/2011;  01411B000 exp. 01/12/2012; 00611E000 exp. 04/16/2012;
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Algeria, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, India, Indonesia, Ireland, Italy, Japan, Jordan, Latvia, Libya, Lithuania, Luxembourg, Malaysia, Mauritania, Mexico, Netherlands, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Korea, Spain, Switzerland, Taiwan, Trinidad & Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Venezuela.
  • Description du dispositif
    ARCHITECT C-Peptide Reagent Kit; a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System; Produced by Biokit S.A., 08186 Barcelona, Spain for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA and Abbott, 65205 Wiesbaden, Germany; list 3L53-25 || The ARCHITECT C-Peptide assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System. The ARCHITECT C-Peptide assay is used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Adresse du fabricant
    Abbott Laboratories, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • 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