Device Recall BioRad

  • Model / Serial
    9450311-1, 9450319, 9450545, 9450547, 9450311, 9451356,   94532016CE
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Bio-Rad brand ''TOX/See Drug Screen Test''; || Catalog numbers: 1945182EX, 1945216, 194-5223
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Source
    USFDA

8 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot number: 3F0001  Exp. 2004-05-15
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The firm distributed to hospitals and diagnostic laboratories nationwide.
  • Product Description
    Platelia Aspergillus EIA
  • Manufacturer
  • Model / Serial
    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
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed to 93 hospitals and medical centers located throughout the US
  • Product Description
    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
  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: CA, IL, MA, MD, ME, NC, ND, NJ, NY, OR, VA and WI.
  • Product Description
    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
  • Model / Serial
    DOA6120272
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution --- USA and countries of Australia and Italy.
  • Product Description
    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
  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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
  • Product Description
    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
3 more