Events

Rappel de Device Recall VP 2000 Processor Heated Reagent Basins

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 Molecular.

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
    56284
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2313-2010
  • Date de mise en oeuvre de l'événement
    2010-07-20
  • Date de publication de l'événement
    2010-08-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93138
  • 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
    Automated Slide Stainer - Product Code KPA
  • Cause
    The vp2000 processor heated reagent basins crack along the bottom seam, have non-uniform coating of interior corners, may be warped, and some may have incorrect dimensions.
  • Action
    Abbott sent Urgent Product Recall letters dated 7/20/10 to the VP 2000 Processor customers on same date via FedEx, informing them that the heated reagent basins could crack along the bottom seam, have non-uniform coating of interior corners, warping of the aluminum housing or incorrect dimensions. These deficiencies could result in leakage or the inability to place the basins into the VP 2000 Processor, resulting in possible exposure to chemical reagents, a slippery floor hazard, and/or delay or failure to start a protocol run. An Abbott Molecular customer service representative will call them to coordinate replacement of all of their heated reagent basins before 10/31/10. Customers were to complete and return the Customer Reply form provided. Any questions were directed to their local Abbott Molecular Representative. *** A second recall letter was sent to all customers on 12/21/10 explaining that the VP 2000 heated reagent basins previously inspected and determined to be acceptable could develop a leak, and that they would be contacted by an Abbott Molecular Customer Service Representative or Field Service representative in early 2011 to coordinate replacement of all of their VP 2000 heated reagent basins. ***

Device

Device Recall VP 2000 Processor Heated Reagent Basins
  • Modèle / numéro de série
    All basins distributed since September 2008.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- Australia, Belgium, France, Germany, India, Italy, Japan, Pakistan, Poland, Russia, Singapore, South Korea, Switzerland, Taiwan, Thailand, United Kingdom, Uruguay, and the United States.
  • Description du dispositif
    VP 2000 Processor Heated Reagent Basins; automated slide stainer; Abbott Molecular Inc., Des Plaines, IL 60018; The basins are sold under the the following part numbers: || a) list 02J11-013, part number 30-144152 (replacement basins); || b) list 02J11-060, part number 30-144100 (as a component of the 100 volt VP 2000 Processor); || c) list 02J11-001, part number 30-144101 (as a component of the 117 volt VP 2000 Processor); || d) list 02J11-004, part number 30-144102 (as a component of the 230 volt VP 2000 Processor); || Designed to automate and standardize FISH slide specimen processing and routine slide staining for the laboratory.
  • Manufacturer
    Abbott Molecular

Manufacturer

Abbott Molecular
  • Adresse du fabricant
    Abbott Molecular, 1300 E Touhy Ave, Des Plaines IL 60018-3315
  • Source
    USFDA