Events

Rappel de Device Recall Her2/Neu (cerbB2) (CB11)

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 Cell Marque Corporation.

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
    77209
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2203-2017
  • Date de mise en oeuvre de l'événement
    2017-05-05
  • Date de publication de l'événement
    2017-06-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-09-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155442
  • 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
    Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer - Product Code NYQ
  • Cause
    Cell marque has determined the need to issue a product recall after identifying product intended to be sold outside the u.S. was not properly labeled as "for export only" as required by section 801 (e )(1) of the fd&c; act.
  • Action
    Cell Marque sent notification letters by e-mail directly to domestic customers who were shipping affected products on May 9, 2017. Letters asked that unused product be destroyed and that amount destroyed and amount already used be recorded on the acknowledgment form and returned per instructions. UPDATE: Firm called DO on May 24, 2017 to inform us that the recall letters did not go out as expected on May 9, 2917 due to employee not performing assigned task. Director of Quality made sure letters went out on May 24th by e-mail and has already received some responses. She will also follow op with personal phone calls. Customers with questions were instructed to contact their Customer Care team at 800-665-7284 or 916-746-8900 or email sevrice@cellmarque.com. For questions regarding this recall call 916-746-8977.

Device

Device Recall Her2/Neu (cerbB2) (CB11)
  • Modèle / numéro de série
    7.0 ml lot 11515602A, expiry 2018-05.
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
  • Description du dispositif
    Her2/Neu (c-erbB-2) (CB-1 1); || 7.0 mL Catalog number 237M-18. || In vitro diagnostic use - Analyte Specific Reagent || Immunology - Analyte Specific Reagent
  • Manufacturer
    Cell Marque Corporation

Manufacturer

Cell Marque Corporation
  • Adresse du fabricant
    Cell Marque Corporation, 6600 Sierra College Blvd, Rocklin CA 95677-4306
  • Société-mère du fabricant (2017)
    Sigma-Aldrich Co. Llc
  • Source
    USFDA