Events

Rappel de Device Recall Leica ASP6025 Advanced Smart Processor Vacuum Tissue Processor

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 Leica Microsystems, 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
    63935
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1815-2013
  • Date de mise en oeuvre de l'événement
    2012-11-13
  • Date de publication de l'événement
    2013-07-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115072
  • 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
    Processor, tissue, automated - Product Code IEO
  • Cause
    The instruction for use 1v9 ref f and all previous versions specify incorrect dimensions for the ready to use (rtu) bottles from other suppliers than leica. in case of a pressure failure of the device in combination with a bottle with incorrect dimensions, overflow can cause contamination of reagents. additionally, the current instructions for use does not highlight the importance to check the filling levels of all reagent bottles (rtu and system bottles) prior to every process run. without this important information, risk of tissue damage or loss is possible. therefore the missing information will be distributed to all customers by a field service notice.
  • Action
    Leica Biosystems sent an Urgent Field Safety Notice dated December 12, 2012, to all affected customers. The notification included a description of the problem and a recommendation that the personnel who use the equipment only use Leica Ready To Use (RTU) bottles that are already supplied as a standard delivery item with the ASP6025 machine. The personnel are further reminded that reagent bottle levels need to be checked and corrected when necessary. Customers with questions or questions regarding this recall call 847-405-5413.

Device

Device Recall Leica ASP6025 Advanced Smart Processor Vacuum Tissue Processor
  • Modèle / numéro de série
    1) Model ASP6025 120V/50-60 Hz; Serial Numbers: 171, 200, 202, 204, 206, 208, 210, 212, 214, 216, 218, 220, 222, 224, 226, 228, 230, 232, 234, 236, 238, 240, 242, 244, 246, 248, 250, 252, 254, 256, 258, 260, 262, 264, 266, 268, 270, 272, 274, 276, 278, 280, 282, 284, 286, 288, 290, 292, 294;  2) Model ASP6025 230V/50-60 Hz; Serial Numbers: 162, 163, 168, 169, 170, 183, 184, 201, 203, 205, 207, 209, 211, 213, 215, 217, 219, 221, 223, 225, 227, 229, 231, 233, 235, 237, 239, 241, 243, 245, 247, 249, 251, 253, 255, 257, 259, 261, 263, 265, 267, 269, 271, 273, 275, 277, 279, 281, 283, 285, 287, 289, 291, 293, 295, 297, 299, 301, 303, 305, 307, 309, 311, 313, 315, 317, 319, 320, 321, 323, 325, 327, 328, 329, 331, 333, 335, 337, 339
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Australia, Belgium, Brazil, Chile, France, Germany, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands, Philipines, Singapore, South Africa, Spain, Switzerland, Thailand, Turkey, and United Kingdom.
  • Description du dispositif
    Leica ASP6025 Vacuum Tissue Processor || The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.
  • Manufacturer
    Leica Microsystems, Inc.

Manufacturer

Leica Microsystems, Inc.
  • Adresse du fabricant
    Leica Microsystems, Inc., 1700 Leider Ln, Buffalo Grove IL 60089-6622
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA