Devices

Device Recall BioRad

  • Modèle / numéro de série
    Lot # & Expiration dates: 1L044 3/31/03; 2C047 7/31/03; 2H049 9/30/03; 2L050 9/30/03; 2M051 9/30/03; 2M052 11/30/03; 3D053 10/31/04; 3H0055 10/31/04; 3K0054 10/31/04; 4A0056 7/5/2005
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed to 93 hospitals and medical centers located throughout the US
  • Description du dispositif
    Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN DETECTION SYSTEM 79674 IN VITRO TEST DIAGNOSTIC USE Distributed in the U.S. by Bio-Rad Laboratories Diagnostics Group 6565 185th Avenue NE, Redmond, WA 98052-5039. Side of kit states Bio-Rad 3, boulevard Raymond Poincare France.
  • Manufacturer
    Bio Rad Laboratories, Inc.
  • 1 Event

Fabricant

Bio Rad Laboratories, Inc.
  • Adresse du fabricant
    Bio Rad Laboratories, Inc., 6565 185th Ave Ne, Redmond WA 98052-5039
  • Source
    USFDA

8 dispositifs médicaux avec un nom similaire

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Device Recall BioRad Laboratories
  • Modèle / numéro de série
    Lot number: 3F0001  Exp. 2004-05-15
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    The firm distributed to hospitals and diagnostic laboratories nationwide.
  • Description du dispositif
    Platelia Aspergillus EIA
  • Manufacturer
    Bio Rad Laboratories, Inc.
Device Recall BioRad
  • Modèle / numéro de série
    9450311-1, 9450319, 9450545, 9450547, 9450311, 9451356,   94532016CE
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    60 consignees received the product in the US and 6 international consignees received the product. Distribution is limited to the following countries: Canada, France, UK, Germany and Italy.
  • Description du dispositif
    Bio-Rad brand ''TOX/See Drug Screen Test''; || Catalog numbers: 1945182EX, 1945216, 194-5223
  • Manufacturer
    Bio-Rad Laboratories Inc
Device Recall BIORAD ANTIBORRELIA (LYME) MICROPLATE EIA Kit
  • Modèle / numéro de série
    Lot #120960 (121003. 121058,121002), ; Exp./Cad/Verw/bis: 2013-09; Catalog#802-3011; 25271, 25272, 25273; Label P/N 522-0040, 522-0037, 522-0011
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: CA, IL, MA, MD, ME, NC, ND, NJ, NY, OR, VA and WI.
  • Description du dispositif
    ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.
  • Manufacturer
    Innominata Dba Genbio
Device Recall BioRad TOX/See
  • Modèle / numéro de série
    DOA6120272
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution --- USA and countries of Australia and Italy.
  • Description du dispositif
    Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Product is distributed by Bio-Rad Laboratories, Inc., Hercules, CA
  • Manufacturer
    Bio-Rad Laboratories Inc
Device Recall BioRad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set
  • Modèle / numéro de série
    Medical device, intended for percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography, intended for professional use only.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed to 127 customers throughout the US and internationally to Argentina, Australia, Canada, Chile, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, New Zealand, Poland, Singapore, Sweden, Taiwan, and the United Kingdom
  • Description du dispositif
    Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model Number 270-2101NU Manufactured by Bio-Rad Laboratories, Hercules, CA
  • Manufacturer
    Bio-Rad Laboratories Inc
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