Devices

Device Recall Cliniqa Liquid QCTM Cardiac Marker Control

  • Model / Serial
    Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039)  Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 2 (List #06F12-10; Lot Number 081039)  Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 3 (List #06F12-11; Lot Number 091039)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AZ, GA, ID, IL, LA, MD, MO, MN, NC, NV, OK, PA, TN, TX, VA and WI; and country of: Italy.
  • Product Description
    Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039) || Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 2 (List Number 06F12-10; Lot Number 081039) || Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 3 (List Number 06F12-11; Lot Number 091039) || Usage: Assayed human plasma which may be used to verify the integrity of newly received i-STAT CK-MB cartridges.
  • Manufacturer
    Abbott Point Of Care Inc.
  • 1 Event

Manufacturer

Abbott Point Of Care Inc.
  • Manufacturer Address
    Abbott Point Of Care Inc., 400 College Rd E, Princeton NJ 08540-6607
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • 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