Events

Rappel de Device Recall Instrumentation Laboratory

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Instrumentation Laboratory Co..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    58996
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2804-2011
  • Date de mise en oeuvre de l'événement
    2011-05-31
  • Date de publication de l'événement
    2011-07-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-11-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102287
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Electrode, ion specific, potassium - Product Code CEM
  • Cause
    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
  • Modèle / numéro de série
    All in date cartridges
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Instrumentation Laboratory Co., 180 Hartwell Road, Bedford MA 01730-2443
  • Société-mère du fabricant (2017)
    Werfenlife Sa.
  • Source
    USFDA