Events

Rappel de Device Recall Mach 4 Universal HRP Polymer Kit

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
    73752
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1523-2016
  • Date de mise en oeuvre de l'événement
    2016-03-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-06-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144876
  • 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
    Biocare medical has identified a single lot (082715) of its mach 4 hrp polymer kit in which some few mach 4 mouse probe vials may have been mislabeled as hrp-polymer.
  • Action
    Biocare Medical sent a Medical Device Recall Notification letter dated March 31, 2016 to affected US customers by USPS. Foreign consignees were also notified per their various government regulations. The letter identified the affected product, problem and actions to be taken. Customers were requested to complete and return by April 15, 2016 the enclosed Return Response Form.

Device

Device Recall Mach 4 Universal HRP Polymer Kit
  • Modèle / numéro de série
    Lot number 082715;  Expiry 01/2017.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in the states of: KS, CA, AZ, OR, FL, KS, CO, MA, KY, NY, IL, OR, MO, NC, TX, PA, OK. SC, TN, PA, TN, GA, and OR. Hungary, Canada, Boliva
  • Description du dispositif
    Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; || Catalog number M4U534L; || For In Vitro Use || Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and rabbit IgG primary antibodies on formalin-fixed, paraffin-embedded (FFPE) tissues in an immunohistochemistry (IHC) procedure. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
  • 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