Events

Recall of Device Recall IMMULITE 2000/IMMULITE 2000 XPi Sex Hormone Binding Globulin

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

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
    76770
  • Event Risk Class
    Class 2
  • Event Number
    Z-2166-2017
  • Event Initiated Date
    2017-01-31
  • Event Date Posted
    2017-04-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154134
  • 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, testosterones and dihydrotestosterone - Product Code CDZ
  • Reason
    Certain lots of sex hormone binding globulin (shbg) do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored at 2-8¿c, as published in the instructions for use (ifu). adjustors stored at 2-8c after 14 days may show a bias in patient samples and quality control falling outside of published ranges. lookback not recommended.
  • Action
    Siemens issued an Urgent Medical Device Correction (UMDC) to customers using the affected SHBG adjustor lots. Customers were advised to store the affected reconstituted adjustor lots at 2-8C or -20C for up to 14 days, after which they must be discarded. The IMMULITE/IMMULITE 1000 SHBG is not affected by this issue. Customers with questions were instructed to contact their Siemens Customer Care Center or their local Siemens technical support representative. For questions regarding this recall call 914-631-8000.

Device

Device Recall IMMULITE 2000/IMMULITE 2000 XPi Sex Hormone Binding Globulin
  • Model / Serial
    Lot Numbers: 1) 357, 2) 358, 3) 360, 4) 361 & 5) 363  Expiration Dates: 1) 2017-01-30, 2) 2017-03-31, 3) 2017-04-30, 4) 2017-05-31 & 5) 2017-06-30
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    SHBG IMMULITE 2000/IMMULITE 2000 XPi || For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SHBG in serum, as aid in the differential diagnosis of hirsutism.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA