Events

Rappel de Device Recall QUANTALyser 240 IFA

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 Inova Diagnostics Incorporated.

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
    79380
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1221-2018
  • Date de mise en oeuvre de l'événement
    2018-01-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162171
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Cause
    The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.
  • Action
    The letters were issued via email on January 26, 2018, informing the consignee of the issue and the actions to be taken. The response forms were requested to be completed and returned by February 23, 2018, indicating receipt of the notification and confirmation that the power supply has been replaced. The firm reported on February 23, 2018 that responses have been received from both consignees. For further questions, please call (858) 586-9900 x 1381.

Device

Device Recall QUANTALyser 240 IFA
  • Modèle / numéro de série
    Serial number 4314
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    There was no U.S. distribution. Distribution was made to Panama and United Kingdom.
  • Description du dispositif
    QUANTA-Lyser 240 IFA, Part #GS0242. || The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates.
  • Manufacturer
    Inova Diagnostics Incorporated

Manufacturer

Inova Diagnostics Incorporated
  • Adresse du fabricant
    Inova Diagnostics Incorporated, 9900 Old Grove Rd, San Diego CA 92131-1638
  • Société-mère du fabricant (2017)
    Werfenlife Sa.
  • Source
    USFDA