Events

Rappel de IMx Theophylline Reagent Pack In Vitro Test

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 Diagnostic International, Ltd..

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
    37957
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0958-2007
  • Date de mise en oeuvre de l'événement
    2007-04-11
  • Date de publication de l'événement
    2007-07-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52441
  • 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
    Theophylline Reagent - Product Code LER
  • Cause
    A decrease in mp values (calibration curve net polarization value) has been observed with this reagent lot at all calibrator levels and may produce the following results: calibration error code 148 (polarization too small), calibration error code 172 (calibration not stored or calibration not accepted) controls out of range (when using a stored calibration curve).
  • Action
    An April 11, 2007, Product Recall Letter was sent to all customers who received the affected lot. All customers who received the affected lot will be contacted. The following communication types were used: Product Recall Letter & Customer Reply Form. Letters were sent to customers by Federal Express Priority mail. The Customers were instructed the following: To discontinue use of and destroy IMx Theophylline reagent lot 41610QI00. If they had forwarded the lots listed in the Product Recall letter to other laboratories, they were instructed to inform them of this Product Recall and provide a copy of this letter to them. They also we instructed to retain a copy of the communication for their records

Device

IMx Theophylline Reagent Pack In Vitro Test
  • Modèle / numéro de série
    Lot #41610Q100; Expiration date 04/25/2008
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide: CA, IL, MA, NY, OR, PA, VA, and WV and countries of Germany and Singapore
  • Description du dispositif
    IMx Theophylline Reagent Pack (List 1A81-20) In Vitro test. || This reagent system is composed of one bottle of Theophylline Pretreatment Solution, one bottle of Theophylline Antiserum (Mouse Monoclonal) and one bottle of Theophylline Fluorescein Tracer.
  • Manufacturer
    Abbott Diagnostic International, Ltd.

Manufacturer

Abbott Diagnostic International, Ltd.
  • Adresse du fabricant
    Abbott Diagnostic International, Ltd., 30 Bo Cruce Davila, Barceloneta PR 00617-3009
  • Source
    USFDA