Events

Rappel de Device Recall MUM1BC5, Concentrated and Prediluted Rabbit Monoclonal antibody

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 Biocare Medical Llc.

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
    70010
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0965-2015
  • Date de mise en oeuvre de l'événement
    2014-12-12
  • Date de publication de l'événement
    2015-01-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132108
  • 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
    Immunohistochemistry reagents and kits - Product Code NJT
  • Cause
    Three lots of mum-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed.
  • Action
    Biocare sent a Medical Device Recall notifications letter to all customers by traceable method. The letters identified the affected product, problem and actions to be taken. Users are asked to immediately discontinue used of the affected lots and dispose of them according to applicable national, state and local laws. Users are requested to complete and return the response form so that proper credit can be issues 800-799-9499.

Device

Device Recall MUM1BC5, Concentrated and Prediluted Rabbit Monoclonal antibody
  • Modèle / numéro de série
    Lot 061013, Exp 2016/06; Lot 073013, Exp. 2016/07; Lot 071614, Exp. 2017/07.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distrinution - US Nationwide in the states of TX, WI, MO, WV, SC, MA, WA, TN, AZ, CA, IL, NY, LA and countries of Kuwait, India, Venezuela, New Zealand, Turkey, Uruguay.
  • Description du dispositif
    MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; || Product Usage: For In Vitro Diagnostic Use. This antibody may be used as a tool for the identification and the sub classification of lymphoid malignancies || : || Multiple myeloma oncogene-1 (MUM-1) is a protein encoded by MUM-1 gene. MUM-1 protein is expressed in the nuclei and cytoplasm of plasma cells and a small percentage of germinal center (GC) B-cells located in the light zone. MUM-1 [BC5] labels MUM-1protein in centrocytes and their progeny, plasma cells, activated T-cells and a wide spectrum of hematolymphoid neoplasms derived from these cells. MUM-1 has been reported to play an important role in mediating B-cell activation and differentiation.
  • Manufacturer
    Biocare Medical Llc

Manufacturer

Biocare Medical Llc
  • Adresse du fabricant
    Biocare Medical Llc, 4040 Pike Ln, Concord CA 94520-1227
  • Société-mère du fabricant (2017)
    Biocare Medical LLC
  • Source
    USFDA