Events

Rappel de Device Recall Pacific Hemostasis Fibrinogen Degradation Products

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 Fisher Diagnostics.

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
    77340
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2762-2017
  • Date de mise en oeuvre de l'événement
    2017-05-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-06-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155789
  • 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
    System, fibrinogen determination - Product Code KQJ
  • Cause
    An issue was discovered with the pacific hemostasis fibrinogen degradation products (fdp) kit, list number 100650, lot 948546 and fdp latex reagent, list 100651, lot 890199. while the kit performs accurately at fdp concentrations greater than 20 ¿g/ml, there is an observed reduction in sensitivity when fdp levels are less than 20 ¿g/ml. this reduction in sensitivity has been tied to fdp latex reagent lot 890199 and may result in false negatives.
  • Action
    ThermoFisher Scientific sent an MEDICAL DEVICE RECALL Letter dated May 16, 2017, to all affected customers and response forms were sent to customers on May 19, 2017. Customers are informed of the recall and potential health risks and instructed to review their test results. Review your inventory and any product on hand is to be discarded. --- The firm ceased distribution of the lots and began its investigation. The held product will ultimately be destroyed. Level A effectiveness checks will be conducted to the consignees and repeated attempts will be made to non-responding customers. The firm will track all mailed, emailed and faxed return forms for the duration of the recall. For further questions, please call (540) 869-8188.

Device

Device Recall Pacific Hemostasis Fibrinogen Degradation Products
  • Modèle / numéro de série
    Lot Number 948546, Exp. 9/30/2017
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA (nationwide) including Puerto Rico, and Internationally to Colombia
  • Description du dispositif
    Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.
  • Manufacturer
    Fisher Diagnostics

Manufacturer

Fisher Diagnostics
  • Adresse du fabricant
    Fisher Diagnostics, 8365 Valley Pike, Middletown VA 22645-1905
  • Source
    USFDA