Events

Recall of Device Recall Instrumentation Laboratory GEM Premier

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
    37719
  • Event Risk Class
    Class 2
  • Event Number
    Z-0778-2007
  • Event Initiated Date
    2007-03-27
  • Event Date Posted
    2007-05-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51374
  • 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
    Laboratory Analyzer - Product Code CHL
  • Reason
    Instrument in micro sampling mode failed to aspirate and no error code was generated and an incorrect patient report could result.
  • Action
    Instrumentation Labs on 3/2707 notified Service Reps to perform on site mandatory upgrade. The foreign counterparts were advised by email on 3/21/07

Device

Device Recall Instrumentation Laboratory GEM Premier
  • Model / Serial
    Serial numbers prior to 07020343 with Software versions prior to V1.1.3
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Australia, Austria, Greece, Spain, Netherlands, Great Britain, France, Germany, Italy, and Sweden
  • Product Description
    GEM Premier 4000 Laboratory Analyzer
  • Manufacturer
    Instrumentation Laboratory Co.

Manufacturer

Instrumentation Laboratory Co.
  • Manufacturer Address
    Instrumentation Laboratory Co., 113 Hartwell Ave, Lexington MA 02421-3125
  • Source
    USFDA