Events

Rappel de Abbott

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 Laboratories.

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
    33616
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0269-06
  • Date de mise en oeuvre de l'événement
    2005-09-20
  • Date de publication de l'événement
    2005-12-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-11-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42161
  • 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
    Counter, Differential Cell - Product Code GKZ
  • Cause
    The product failed 12-month stability testing that can lead to falsely reduced hemoglobin (hgb) test results.
  • Action
    On September 20, 2005, the firm issued letters to all its direct consignees, informing them of the affected product and providing instructions on the recall. In February, the firm expanded its recall to all lots as a result of having identified an additional failure in a different lot.

Device

Abbott
  • Modèle / numéro de série
    (List Number On the Box---List Number On the bottle---Lot Number):  99226-01---99229-01---15632I2; 08H17-01---08H17-02---15631I2; 08H17-01---08H17-02---15661I2;  08H17-01---08H17-02---16823I2;  08H17-01---08H17-02---17906I2;  08H17-01---08H17-02---17907I2;  08H17-01---08H17-02---18089I2; 08H17-01---08H17-02---19184I2;  08H17-01---08H17-02---19296I2;  08H17-01---08H17-02---20413I2;  08H17-01---08H17-02---21540I2;  08H17-01---08H17-02---22739I2;  08H17-01---08H17-02---23889I2    Expanded: All lots under recall.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution of DILUENT is worldwide to a total of 1,584 consignees. All CELL-DYN 1800 customers were notified via the Device Recall Letter. At the time of receipt of the letter, the customer may or may not have the recalled lots in their inventory. Therefore, the letter directed the customer to assess their inventory of DILUENT 08H17-01 and 99226-01 to determine if they had any of the affected lots in their possession. Foreign countries include: Canada, Columbia, Uruguay, Germany, Barbados, Bermuda, Cayman Islands.
  • Description du dispositif
    Abbott brand CELL-DYN 1800 DILUENT Packaged in 3.8L containers, || List Numbers: || 99226-01, 08H17-01,(on box), 99226-01, 08H17-02 (on bottle); || Product is distributed by Abbott Hematology, 5440 Patrick Henry Dr., Santa Clara, CA 95054
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Adresse du fabricant
    Abbott Laboratories, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
  • Source
    USFDA