Events

Rappel de Device Recall Phadia 1000 Instrument

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 Phadia US 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
    69872
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0947-2015
  • Date de mise en oeuvre de l'événement
    2014-11-20
  • Date de publication de l'événement
    2015-01-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-06-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131895
  • 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, test, radioallergosorbent (rast) immunological - Product Code DHB
  • Cause
    During an investigation of instrument logs it was determined that in specific circumstances involving multiple steps, a rack sequencing error may occur. this will result in a mismatch between the sample id and the test result reported for all subsequent sample racks in that run.
  • Action
    ThermoFisher sent an Urgent Medical Device Product Correction letter to all affected customers. The firm will inform customers of the specific sequence of errors and operator actions that can trigger the event via letter and phone, and will request that they do not respond to the Barcode Read Error and let the sample with the error eject normally from the instrument and be rerun after the barcode read error has been resolved. The firm will issue a mandatory Phadia 1000 Instrument Software (ISW) update that will correct the issue and make efforts to install it within 45 days from date of availability. Customers were asked to return the written response form via fax to: 1-888-243-5214 Attention: Customer Support, Phadia 1000 ISW Product Correction Response; EMAIL: Compliance-us.idd@thermofisher.com Email Subject Line: Phadia 1000 ISW Product Correction Response. Customers with questions were instructed to contact Phadia US Technical Support at 800-346-4364, option 2. For questions regarding this recall call269-492-1957.

Device

Device Recall Phadia 1000 Instrument
  • Modèle / numéro de série
    Part Number 12-3800-01
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AZ, CA, CO, CT, FL, GA, HI IL, IN, KS, MD, MI, MN, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA.
  • Description du dispositif
    Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments.
  • Manufacturer
    Phadia US Inc

Manufacturer

Phadia US Inc
  • Adresse du fabricant
    Phadia US Inc, 4169 Commercial Ave, Portage MI 49002-9701
  • Société-mère du fabricant (2017)
    Fsii Sweden Holdings I Ab
  • Source
    USFDA