Events

Rappel de Device Recall ARCHITECT 25OH Vitamin D 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
    63912
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0698-2013
  • Date de mise en oeuvre de l'événement
    2012-12-12
  • Date de publication de l'événement
    2013-01-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114995
  • 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
    System test Vitamin d - Product Code MRG
  • Cause
    The architect 25-oh vitamin d assay has the potential to generate falsely elevated or falsely depressed results when used with certain lots of architect reaction vessels.
  • Action
    Abbott Laboratories sent a "Product Correction Immediate Action Required" letter dated December 12, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to immediately discontinue use and destroy any remaining inventory of the reaction vessel lots listed; to clear the ARCHITECT RV hopper of impacted RV lots following the instructions provided, prior to continued use of the ARCHITECT 25-OH Vitamin D assay; to review the patient results obtained with the affected lots with the treating physician or heath care provider to ensure they are aware of the potential analytical issue and can determine whether re-evaluation of the patient is necessary; to forward a copy of the letter to any laboratory to whom they may have forwarded the reagent; and to retain a copy of the letter for their records and to complete and return the Customer Reply Form via fax to: 1-800-777-0051 For further questions please call your local Customer Service representative at 877-422-2688.

Device

Device Recall ARCHITECT 25OH Vitamin D Reagent Kit
  • Modèle / numéro de série
    ARCHITECT 25-OH Vitamin D Reagent Kit list 3L52, lot numbers 02412C000, exp. 12/26/2012; 02512C000, exp. 12/26/2012; 02012G000, exp. 7/16/2013; 01612G000, exp. 7/17/13; 00912G000, exp. 7/10/13; 02512I000, exp. 10/8/2013; 02612I000, exp. 10/8/2013; 03512I000, exp. 10/10/2013; 03712I000, exp. 10/10/13; when used with ARCHITECT Reaction Vessel (RV) list 7C15-01, box lot numbers (bag lot numbers): 19320P100 (6F9891501); 19344P100 (4N5891091); 19404P100 (1J1948151);  19322P100 (LM3891731); 19373P100 (6F9891521); 19407P100 (4N5948361); 19324P100 (NK8891921); 19374P100 (JG7891631); 19408P100 (5P4948471); 19340P100 (1J1890911); 19375P100 (LM3891741); 19497P100 (2L2948281); 19341P100 (2L2891001); 19379P100 (NK8891931); 20026P100 (LM3947841)
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and the countries of Austria, Barbados, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Latvia, Libya, Malaysia, Netherlands, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
  • Description du dispositif
    Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-37 (U.S.) (5 x 100 tests); in vitro diagnostic.
  • 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