Device Recall CD99

  • Model / Serial
    Catalog number PM008 AA; Lot numbers: 110912, Exp 2015/11; 041913, Expiry 2016/04; 120313, Expiry 2016/12; 110314, Expiry 2017/11.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US nationwide in the states of TX, KS, OK, NJ, LA, GA, NC, SC, VA, and the countries of Spain, Austria, Ecuador, Dominican Republic, Vietnam, Kuwait, Hungary and Israel.
  • Product Description
    CD99 || Catalog number PM008 AA; || For In Vitro Diagnostic Use. || Product Usage: || Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Biocare Medical, LLC, 4040 Pike Ln, Concord CA 94520-1227
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Lot Number 1113202A, Exp date: 2014-04.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) include state of : CA and country of: Great Britain.
  • Product Description
    Cell Marque antibody CD99 (H036-1.1) || Mouse Monoclonal Antibody. || Cel Marque, 6600 Sierra College Boulevard, Rocklin, Ca 95677 || The Cell Marque CD99 Mouse Monoclonal Antibody is intended for qualified laboratories to qualitatively identify by light microscopy, the presence of associated antigens in sections of formalin fixed, paraffin embedded tissue sections using manual or automated IHC test methods. Use of this antibody is indicated as an aid in diagnostic determination of human tumors within the context of the patient's clinical history and other diagnostic tests evaluated by a qualified pathologist of physician.
  • Manufacturer