Device Recall Alere Cholestech LDX hsCRP Test Cassette,

  • Model / Serial
    Model Number 12-807. ¿ Lot/Unit Codes: 274632, 281847 ¿ Expiration date, or Expected shelf life: 5/5/13, 6/30/13
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution
  • Product Description
    The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. || Product Usage: || Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum.
  • Manufacturer
  • 1 Event

Manufacturer

  • 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
    USFDA