Devices

Device Recall InSite

  • Modèle / numéro de série
    Lot Numbers: RD1340205, RD1340205X, RD1340205Y
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide. Italy, and United Kingdom. The product was released for distribution to 21 consignees nationwide to CA, FL, GA, IA, IL, NC, NJ, NY, TX, VT, WA, and WI. One VA account: VA Medical Center, Gwen Levy, Bld. 500, Room 1238, 11301 Wilshire Blvd., Los Angeles, CA 90073. 2 overseas consignees distributed the product to Italy (Space Imports Export SPL, Via Ranzato, 12, 1-20128 Milano, Italy and United Kingdom (Launch Diagnosis, West Yoke Farm unit 11, Michaels, Lane, Sevenoaks, Kent, TN15 7EP United Kingdom
  • Description du dispositif
    Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu IHC Kit, Manual; || Model Numbers: RD134-60K; || Lot Numbers: RD1340205, RD1340205X, RD1340205Y
  • Manufacturer
    Biogenex Laboratories
  • 1 Event

Fabricant

Biogenex Laboratories
  • Adresse du fabricant
    Biogenex Laboratories, 4600 Norris Canyon Rd, San Ramon CA 94583-1320
  • Source
    USFDA

3 dispositifs médicaux avec un nom similaire

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Device Recall InSite
  • Modèle / numéro de série
    Lot Numbers: RD1340205, RD1340205X, RD1341105, RD1340206
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide. Italy, and United Kingdom. The product was released for distribution to 21 consignees nationwide to CA, FL, GA, IA, IL, NC, NJ, NY, TX, VT, WA, and WI. One VA account: VA Medical Center, Gwen Levy, Bld. 500, Room 1238, 11301 Wilshire Blvd., Los Angeles, CA 90073. 2 overseas consignees distributed the product to Italy (Space Imports Export SPL, Via Ranzato, 12, 1-20128 Milano, Italy and United Kingdom (Launch Diagnosis, West Yoke Farm unit 11, Michaels, Lane, Sevenoaks, Kent, TN15 7EP United Kingdom
  • Description du dispositif
    Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu IHC Kit, Automated; || Model Numbers: RD134-YAX; || Lot Numbers: RD1340205, RD1340205X, RD1341105, RD1340206
  • Manufacturer
    Biogenex Laboratories
Device Recall InSite
  • Modèle / numéro de série
    Lot Numbers: AM134P1005
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide. Italy, and United Kingdom. The product was released for distribution to 21 consignees nationwide to CA, FL, GA, IA, IL, NC, NJ, NY, TX, VT, WA, and WI. One VA account: VA Medical Center, Gwen Levy, Bld. 500, Room 1238, 11301 Wilshire Blvd., Los Angeles, CA 90073. 2 overseas consignees distributed the product to Italy (Space Imports Export SPL, Via Ranzato, 12, 1-20128 Milano, Italy and United Kingdom (Launch Diagnosis, West Yoke Farm unit 11, Michaels, Lane, Sevenoaks, Kent, TN15 7EP United Kingdom
  • Description du dispositif
    Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu Monoclonal Antibody, Automated; || Model number: AM134-10MP; || Lot Numbers: AM134P1005
  • Manufacturer
    Biogenex Laboratories
Device Recall InSite HER2/neu Detection Kit
  • Modèle / numéro de série
    Catalog number RD471-60K: Lot numbers: RD4710111, Exp Jan 2012; RD4710411, Exp. Apr 2012; RD4711013, Exp Oct 2014.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Brazil and Ecuador. No US distribution
  • Description du dispositif
    InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
  • Manufacturer
    Biogenex Laboratories, Inc.