Events

Rappel de Device Recall MESOMARK

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 Fujirebio Diagnostics, 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
    56427
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1606-2011
  • Date de mise en oeuvre de l'événement
    2010-07-29
  • Date de publication de l'événement
    2011-03-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93728
  • 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
    Cancer monitoring test system, soluble mesothelinrelated peptides, epithelioid/biphasic mesothelioma - Product Code OAW
  • Cause
    Presence of material attached to the bottom of some wells in places visible to the naked eye, which caused an overestimation of the sample.
  • Action
    Notification dated 7/7/10 was sent to the customer via e-mail and FedEx Priority Overnight. FUJIREBIO Diagnostics, Inc. sent an URGENT PRODUCT CORRECTION NOTIIFICATION letter dated July 7, 2010, to all affected customers via e-mail and FedEx Priority Overnight. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue using MESOMARK kit. Lot 57K04510 and discard any remaining inventory. Complete and return the attached Confirmation of Receipt form upon receipt of this notification, no later than July 30, 2010. Notify your ordering physician or health care provider as appropriate. For questions regarding this recall call 877-861-7246 or 610-240-3800.

Device

Device Recall MESOMARK
  • Modèle / numéro de série
    Lot: 57K04510, Item # 801-905, Expiration Date: December 14, 2010 and Lot: 57K04409, Item# 801-905, Expiration Date: June 15, 2010
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    HDE
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including UT
  • Description du dispositif
    MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring of patients diagnosed with mesothelioma. Each kit contains 96 tests. || MESOMARK is an enzyme linked immunosorbent assay (ELISA) for the quantitative measurement of Soluble mesothelin Related Peptides (SMRP) in human serum. Measurement of SMRP may aid in the monitoring of patients diagnosed with epithelioid or biphasic mesothelioma. MESOMARK values must be interpreted in conjunction with all other available clinical and laboratory data.
  • Manufacturer
    Fujirebio Diagnostics, Inc.

Manufacturer

Fujirebio Diagnostics, Inc.
  • Adresse du fabricant
    Fujirebio Diagnostics, Inc., 201 Great Valley Pkwy, Malvern PA 19355-1308
  • Société-mère du fabricant (2017)
    Miraca Holdings, Inc.
  • Source
    USFDA