Events

Recall of Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software.

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

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
    26892
  • Event Risk Class
    Class 3
  • Event Number
    Z-1138-03
  • Event Initiated Date
    2003-06-13
  • Event Date Posted
    2003-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-11-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28686
  • 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
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
  • Reason
    Version 2.6 software was released however it will not properly handle adjustment slopes.
  • Action
    Recall Technical Bulletins were sent out on 6/13/2003 to all Immulite 2000 users instructing them to not install the provided version 2.6 software.

Device

Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2...
  • Model / Serial
    All units.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Software was distributed to Immulite 2000 users throughout the nation. These units are found in hospitals and clinics. Software was also distributed to the firm''s service representatives.
  • Product Description
    Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software.
  • Manufacturer
    DPC Cirrus

Manufacturer

DPC Cirrus
  • Manufacturer Address
    DPC Cirrus, 62 Flanders-Bartley Road, Flanders NJ 07836
  • Source
    USFDA