Events

Recall of Device Recall Instrumentation Laboratory

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Instrumentation Laboratory Co..

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
    58996
  • Event Risk Class
    Class 1
  • Event Number
    Z-2803-2011
  • Event Initiated Date
    2011-05-31
  • Event Date Posted
    2011-07-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100798
  • 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
    Electrode, ion specific, potassium - Product Code CEM
  • Reason
    K+ results on the gem premier 4000 are too low when compared to a reference analyzer, with biases exceeding allowable error claim of a¿ 0.5 moul.
  • Action
    The firm, Instrumentation Labs, issued a Revised "Urgent Field Safety Notification" letter dated July 14, 2011, to GEM Premier 4000 customers. The letter describes the product, problem, updated issue description and actions to be taken. The customers were instructed to follow the instructions to Disable K+ Parameter ,provided in the letter, to eliminate the potential of erroneous K+ result reporting and to complete and return the MANDATORY RESPONSE TRACKING FORM immediately via fax at 781-861-4207 or email to ra-usa@ilwww.com. The letter also noted an Important Change to Customer Actions from June Urgent Field Safety Notification. Prior strategy : Instrumentation Laboratories (IL) notified U.S and Canadian customers via the Urgent Field Safety Notification mailed USPS between June 2 - 3,2011. International Affiliates / Dealers notified through e-mail on June 1, 2010. A response (tracking) form was included. A Worldwide Regulatory Notice was e-mailed on May 31.2011.to IL country affiliates and distributors, notifying them of the issue, providing a risk summary and the support documentation for the notification. The customer notification will be handled per their local regulatory requirements. If you have questions regarding this notification, please contact IL at 800-678-0710, press 2 at prompt.

Device

Device Recall Instrumentation Laboratory
  • Model / Serial
    All in date cartridges
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: CANADA, ARGENTINA, AUSTRALIA ,AUSTRIA, BELGIUM, BRAZIL, CHILE, CHINA, CROATIA (local name: Hrvatska), CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, MALAYSIA, MEXICO, NETHERLANDS, NORWAY, PANAMA, POLAND, PORTUGAL, PUERTO RICO, SAUDI ARABIA, SLOVENIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VIET NAM.
  • Product Description
    GEM PREMIER 4000 CARTRIDGE K+ REPORTING: || GEM 4000 BG/Hct/Lytes/G/L/CO-Ox/tBili : || 75 test iQM Part Number:00027407511 || 150 test iQM Part Number: 00027415011 || 300 test iQM Part Number: 00027430011 || 450 test iQM Part Number: 00027445011 || 600 test iQM part Number: 00027360011 || The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, 02Hb, COHb, MetHb, HHb) parameters.
  • Manufacturer
    Instrumentation Laboratory Co.

Manufacturer

Instrumentation Laboratory Co.
  • Manufacturer Address
    Instrumentation Laboratory Co., 180 Hartwell Road, Bedford MA 01730-2443
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    USFDA