Events

Rappel de Device Recall Simplastin Excel

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 Biomerieux, 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
    25587
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0629-03
  • Date de mise en oeuvre de l'événement
    2003-02-04
  • Date de publication de l'événement
    2003-03-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2004-01-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26108
  • 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
    Test, Time, Prothrombin - Product Code GJS
  • Cause
    Product is being recalled due to vial to vial variability of clotting time results.
  • Action
    Consignees were notified by a Customer Notification letter sent via regular mail on/about February 4, 2003 with response form attached. An additional cover letter was sent to international affiliates/distributors who were responsible for notifying their customers. Consignees were asked to report the amount of product on hand and to destroy the product. On March 18th the firm expanded the recall. Consignees were notified by letter on March 19th , and March 31, 2003 and were advised to stop using the affected lot numbers, destroy the remaining material in inventory and to contact their local bioMerieux Customer Service representative for replacement.

Device

Device Recall Simplastin Excel
  • Modèle / numéro de série
    Lot numbers: 161402, 161431, 161432, 161477, 161448, 161479, 161507, 161508, 161550, 161551, 161583, 161585, 161595, 161657, 161658. Expanded 3/19/2003 to include lot #161639, 16160 and 1611711. Final expansion of recall initiated 5/30/2003 to include Product Number 252001 (20ml), lot numbers161403, 161480, 161509, 161510, 161552 161586 and 161596.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed nationwide and Brazil, Canada, China, Japan, Korea, Mexico, The Netherlands, Taiwan, Venezuela
  • Description du dispositif
    Simplasitin Excel, 10 x 6ml, 25200, For Prothrombin Time determinations, bioMerieux, Inc. Durham, NC 27704. The product consists of two vials, a thromboplastin reagent and a diluent ( the vials are mixed together before use).
  • Manufacturer
    Biomerieux, Inc.

Manufacturer

Biomerieux, Inc.
  • Adresse du fabricant
    Biomerieux, Inc., 100 Rodolphe Street, Durham NC 27712
  • Source
    USFDA