Events

Recall of Device Recall Cliniqa Liquid QCTM Cardiac Marker Control

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Point Of Care Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63309
  • Event Risk Class
    Class 3
  • Event Number
    Z-0192-2013
  • Event Initiated Date
    2012-07-19
  • Event Date Posted
    2012-11-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113476
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Enzyme controls (assayed and unassayed) - Product Code JJT
  • Reason
    Abbott point of care (apoc) has determined that for the cliniqa liquid qc cardiac marker control for i-stat level 1 (list #06f12-09; lot number 071039); i-stat level 2 (list #06f12-10; lot number 081039); and i-stat level 3 (list #06f12-11; lot number 091039) results may be generated below the lower value assignment range for some vials.
  • Action
    The firm, Abbott Point of Care, Inc. (APOC), sent an "URGENT RECALL NOTICE" dated July 2012 via FED-EX on July 19, 2012. The recall notice identified the product, problem and the action needed to be taken by the customer. The customers were instructed to discontinue use of the control lot numbers; return all unused controls on the enclosed Customer Reply Form; If another institution was provided the controls, provide a copy of this notice to them. Note: if any used vials gave acceptable product performance, a review of the cartridge performance and associated patient results is not necessary) Note: APOC is shipping replacement products to customers facilities to minimize any disruption this might cause. If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020, option 1 or your Abbott Point of Care representative.

Device

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.

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