Events

Recall of IMMULITE /IMMULITE 1000 Systems COR

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

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
    69321
  • Event Risk Class
    Class 2
  • Event Number
    Z-0122-2015
  • Event Initiated Date
    2014-09-19
  • Event Date Posted
    2014-10-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130224
  • 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
    Radioimmunoassay, cortisol - Product Code CGR
  • Reason
    Customer complaints were received for positive bias reported on the controls used on the immulite /immulite 1000 on the cortisol assay reagent lots immulite /immulite 1000 (lkco1) lots 381,382 and 383 . subsequently, the firm confirmed a positive bias on the immulite/immulite 1000 (lkco1) lots 381, 382 and 383.
  • Action
    US Customers were sent an Urgent Medical Device Recall Letter (UMDR2014-09-19, dated 9/19/14) via FedEx on 9/19/14. Outside US Customers were sent an Urgent Field Safety Notice Letter. The letters inform the consignees of the recall of the IMMULITE/IMMULITE 1000 Cortisol (LKCO1) assay, kit lots 381, 382 and 383. Customers were asked to take the following actions: - Please review this letter with your Medical Director. - Discontinue use of and discard the IMMULITE/IMMULITE 1000 Cortisol kit lots listed in the letter. - Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. --- Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Field Safety Notice letter within thirty (30) days.

Device

IMMULITE /IMMULITE 1000 Systems COR
  • Model / Serial
    Lots: 381 (exp. 10/31/2014), 382 (exp. 10/31/2014) and 383 (exp. 11/30/2014)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and internationally to Canada.
  • Product Description
    IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. || For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

Siemens Healthcare Diagnostics
  • Manufacturer Address
    Siemens Healthcare Diagnostics, 511 Benedict Ave, Tarrytown NY 10591-5005
  • Source
    USFDA