Events

Rappel de Device Recall Synchron Acetaminophen (ACTM) Reagent

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 Beckman Coulter 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
    49069
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2405-2008
  • Date de mise en oeuvre de l'événement
    2008-07-10
  • Date de publication de l'événement
    2008-09-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72692
  • 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
    Reagent - Product Code LDP
  • Cause
    This recall was initiated after beckman coulter verified through testing that acetaminophen reagents (lots #m702524 & m703276) manufactured with contaminated heparin has shown a negative bias in performance between the assay made with contaminated and uncontaminated heparin.
  • Action
    The initial customer notifications with fax back response forms were mailed via US Postal Service beginning on 07/21/2008. The letter asked their customers to please discontinue use and discard appropriately the affected lots of Synchron Acetaminophen Reagent (M703276 & M702524). Customers were also instructed to contact their Customer Service Representative at (800) 526-3821 in the United States or (800) 463-7828 in Canada or, if they are outside the US or Canada, please contact your local Beckman Coulter Representative to discuss replacement options. They were also instructed to complete and return the enclosed response form within 10 days. In addition, the customers were informed that the contaminated Heparin was used in the following Beckman Coulter, Inc., products: Synchron Theophylline (THE) Reagent (lot # M701460), Synchron Phenytoin (PHY) Reagent and Synchron C-Reactive Protein (CRP) Reagent (lot# M703222, M703266, M703267 & M703268), however Beckman Coulter has verified through testing that the performance of these products are not affected.

Device

Device Recall Synchron Acetaminophen (ACTM) Reagent
  • Modèle / numéro de série
    Lot Numbers M703276 and M702524
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Canada
  • Description du dispositif
    Synchron Acetaminophen (ACTM) Reagent, Part Number 472169. || ACTM Reagent when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 Systems and SYNCHRON Systems Drug Calibrator 2 set, is intended for quantitative determination of Acetaminophen concentration in human serum or plasma.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • Adresse du fabricant
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA