Device Recall BIORAD ANTIBORRELIA (LYME) MICROPLATE EIA Kit

  • 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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Innominata Dba Genbio, 15222 Avenue Of Science Ste A, San Diego CA 92128-3422
  • Manufacturer Parent Company (2017)
  • Source
    USFDA