Events

Rappel de Smooth Muscle Actin (SMA) 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
    72160
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0252-2016
  • Date de mise en oeuvre de l'événement
    2015-09-08
  • Date de publication de l'événement
    2015-11-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-01-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140026
  • 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
    Certain catalog numbers and lots of smooth muscle actin may stain some cell types that are typically expected to be negative for sma.
  • Action
    Biocare sent a Medical Device Recall Notification letter dated September 8, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue and dispose of all affected product. Customers were asked to complete an return the enclosed Return Response Form. Customer's accounts would be credited for all affected product. For questions regarding this recall call 925-603-8033.

Device

Smooth Muscle Actin (SMA) antibody
  • Modèle / numéro de série
    Catalog numbers:  CME305A & CME305B: lots 110112, Expiry 11/2015;0 42213, expiry 4/2016; 101013, expiry 10/2016; 121813, expiry 12/2016; 070214, expiry 7/2017; 020215, expiry 2/2018.  Catalog number: PME305AA, lots 070513, expiry 07/2016; 032114, expiry 3/2017, 030315, expiry 3/2018.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including CO, FL, OH, SC, AZ, AL, FL, CT, NJ, CA, DC, KY, NC, TX, ID, MA, MD, OR, LA, PA, KS, NY, UT, GA and Internationally to Spain, Sweden, Switzerland, Hungary, Italy, Germany, Turkey, Canada, India, Bolivia, Mexico, Indonesia and Australia.
  • Description du dispositif
    Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6.0 ml prediluted and ready to use. They are the same product with the same intended use. || Chemistry - IVD Smooth Muscle Actin (SMA) antibody recognizes the alpha-smooth muscle isoform of actin. This antibody recognizes the alpha-smooth muscle isoform of actin. This MAb is reportedly useful for identifying tumors arising from smooth muscle and myoepithelial cells.
  • 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