Devices

Device Recall InSite

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: RD1340205, RD1340205X, RD1340205Y
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    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
  • 제품 설명
    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

제조사

Biogenex Laboratories
  • 제조사 주소
    Biogenex Laboratories, 4600 Norris Canyon Rd, San Ramon CA 94583-1320
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 3 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall InSite
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: RD1340205, RD1340205X, RD1341105, RD1340206
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    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
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: AM134P1005
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    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
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Catalog number RD471-60K: Lot numbers: RD4710111, Exp Jan 2012; RD4710411, Exp. Apr 2012; RD4711013, Exp Oct 2014.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Brazil and Ecuador. No US distribution
  • 제품 설명
    InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
  • Manufacturer
    Biogenex Laboratories, Inc.