Alere hCG Combo Cassette (20/10 mIU/mL) KIt

  • Model / Serial
    Lot/Unit Codes: hCG1110133 & hCG1110135  Part Number: 92215  Expiration date, or Expected shelf life: 9/30/13 & 10/31/13
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    United States Nationwide Distribution
  • Product Description
    Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. || Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, as an aid in the early detection of pregnancy. It is for healthcare professionals only.
  • Manufacturer
  • 1 Event


  • Manufacturer Address
    Alere San Diego, Inc., 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source