Events

Recall of IMMULITE 2000

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
    32010
  • Event Risk Class
    Class 3
  • Event Number
    Z-0994-05
  • Event Initiated Date
    2005-04-22
  • Event Date Posted
    2005-07-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38925
  • 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
    The transport chain is used to move a reaction tube within the immulite 2000. it goes on to state the error condition that occurs due to a false trip of the home sensor.
  • Action
    The firm became aware of the problem on 4/19 and conducted tests on 4/22/05. A service alert for field service engineers and Immulite 2000 distributors was prepared on 4/22/05.

Device

IMMULITE 2000
  • Model / Serial
    All analyzers; all serial numbers.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    worldwide
  • Product Description
    IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by DPC Cirrus Inc., Flanders, NJ 07836
  • Manufacturer
    DPC Cirrus

Manufacturer

DPC Cirrus
  • Manufacturer Address
    DPC Cirrus, 62 Flanders Bartley Rd, Flanders NJ 07836-4715
  • Source
    USFDA