Events

Rappel de ABX Pentra ML

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 Horiba Instruments, Inc dba Horiba Medical.

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
    63829
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0645-2013
  • Date de mise en oeuvre de l'événement
    2012-09-20
  • Date de publication de l'événement
    2013-01-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-03-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114847
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Cause
    Horiba medical is recalling abx pentra ml because they have confirmed an issue with the abx pentra ml data management and validation system. an incorrect patient result is transmitted to the laboratory information system. this result is from a previous run of the same patient that is stored in the ml database. this issue occurs in a very rare sequence of specific events. the affected software.
  • Action
    .A recall letter dated 11/09/2012 was sent to all their customers who received the ABX PENTRA ML products. The letter informed the customers of the problem identified and the action to be taken. Customers are instructed to complete and return the enclose response form within 10 days. Customers with questions about the letter are instructed to contact their local HORIBA Medical representative. Recall Letter, as produced per FCD-0377, Field Safety Notice & Acknowledgement will be mailed via FedEx to the ten (10) customers noted on the list the week of November 12, 2012. Effectivity will be evaluated by receipt of the Field Safety Notice Acknowledgment Form. Follow-up communications with customers will be conducted, as needed.

Device

ABX Pentra ML

Manufacturer

Horiba Instruments, Inc dba Horiba Medical
  • Adresse du fabricant
    Horiba Instruments, Inc dba Horiba Medical, 34 Bunsen, Irvine CA 92618-4210
  • Société-mère du fabricant (2017)
    Horiba Ltd.
  • Source
    USFDA