Events

Rappel de Device Recall Specimen Gate Laboratory

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 PerkinElmer Life and Analytical Sciences, Wallac, OY.

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
    76648
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1761-2017
  • Date de mise en oeuvre de l'événement
    2017-03-07
  • Date de publication de l'événement
    2017-03-13
  • Statut de l'événement
    Open, Classified
  • 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=153750
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Cause
    Potential for errors in patient results generated by the specimen gate laboratory software.
  • Action
    PerkinElmer Life and Analytical Sciences sent an Urgent Medical Device Correction letter dated March 7, 2017, to all affected consignees. The letter contains the following instructions: Until PerkinElmer's corrective measures are completed, we request our customers to close the Specimen Gate Laboratory Result Viewer between viewing and especially between manually calculating assay results. Closing and reopening the Result Viewer between processing the results from different assays effectively prevents the described issues from occurring. We also request our customers to follow unreported specimens with available tools to avoid any delay in reporting screening results. The available tools will vary depending on their process or the LIMS system that is used for activities associated with management of patient demographics, patient reports and the overall management of data generated from newborn screening testing. The final corrective action will involve an installation update to the software. PerkinElmer will deploy an installation update that will prevent the described issue when assays are calculated during the same Result Viewer session without closing it between the processing of different assays. Once the installation update is available, Software Services will contact you and arrange for the deployment. The installation update will be provided to you free of charge. Customers were instructed to complete the enclosed response form and return it by fax to 1-330-825-8520 (US) =358 2 2678 357 (OUS). For questions regarding this recall call 317-418-1735.

Device

Device Recall Specimen Gate Laboratory
  • Modèle / numéro de série
    Software Version: 1.3 Rev2, 1.7, 1.8, 1.9, 1.9 Rev2
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MD, MI, MO, NV, OH, OK, OR, TN, TX, VA; and Internationally to Canada and Brazil
  • Description du dispositif
    Specimen Gate Laboratory; Product Number: 5002-0180 || Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.
  • Manufacturer
    PerkinElmer Life and Analytical Sciences, Wallac, OY

Manufacturer

PerkinElmer Life and Analytical Sciences, Wallac, OY
  • Adresse du fabricant
    PerkinElmer Life and Analytical Sciences, Wallac, OY, Mustionkatu 6, P.O. Box 10, Turku Finland
  • Société-mère du fabricant (2017)
    Perkin Elmer Inc.
  • Source
    USFDA