Events

Rappel de Device Recall ABX PENTRA Multical. ABX PENTRA N Control ABX PENTRA P Control

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
    67332
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1146-2014
  • Date de mise en oeuvre de l'événement
    2014-01-20
  • Date de publication de l'événement
    2014-03-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-12-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125274
  • 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
    Calibrator, multi-analyte mixture - Product Code JIX
  • Cause
    Horiba medical is informing all abx pentra multical, n control, and p control customers running the creatinine rate blank method assay on the abx pentra 400 and pc200 that the target values for creatinine rate blank method have been updated. this issue is only applicable to creatinine rate blank method values reported on the abx pentra 400 and pc200 chemistry analyzers only. no other analyzers.
  • Action
    HORIBA Medical initiated this recall by sending customers recall communication via FedEx week of January 20, 2014. The recall communication was a Field Safety Notice letter and Acknowledgement Form. The letter, dated 01/20/2014, titled "URGENT SAFETY NOTICE", informed customers of the recall by providing product description and codes, issue, impact, actiona/resolution, and contact information. The letter contained the following attachments: Field Safety Notice Acknowledgement Form and Updated Annexes with re-assigned values.

Device

Device Recall ABX PENTRA Multical. ABX PENTRA N Control ABX PENTRA P Control
  • Modèle / numéro de série
    Model Numbers:Multical - A11A01652, N Control - A11A01653, P Control - A11A01654.  Lot Numbers: MultiCal: 1204101 and 1304901, N Control: 1300801, P Control: 1300601.  Expiration Date (s): MultiCal: 1204101 Expires on 05/31/14, MultiCal: 1304901 Expires on 07/15/15, N Control: 1300801 Expires on 11/05/14, P Control: 1300601 Expires on 11/05/14.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    United States nationwide distribution.
  • Description du dispositif
    ABX PENTRA Multical. || ABX PENTRA N Control. || ABX PENTRA P Control. || The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two || measuring principals: absorbance and ion selective electrodes. || The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical || additives and materials of biological origin. The assigned values of the calibrator || components are given in the enclosed annex, ensuring optimal calibration of the || appropriate HORIBA ABX SAS methods on the ABX PENTRA Clinical Chemistry || Analyzer. This calibrator is provided in ten vials of 3 ml.
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical

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