Events

Recall of Device Recall VITROS Toal T4 Calibrators

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ortho-Clinical 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
    67643
  • Event Risk Class
    Class 2
  • Event Number
    Z-1648-2014
  • Event Initiated Date
    2014-02-20
  • Event Date Posted
    2014-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125895
  • 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
    Enzyme immunoassay, non-radiolabeled, total thyroxine - Product Code KLI
  • Reason
    Total t4 calibrators and reagent packs may have calibration failures or low quality control results.
  • Action
    Ortho Clinical Diagnostics sent an Urgent Product Correction Notifications dated February 19, 2014, to all affected customers via Fed Ex and/or US Postal Service Priority Mail. The letter identified the product the problem and the action needed to be taken by the customer. Customers are advised to immediately discontinue using and discard all remaining affected product. Customers should review their Quality Control results that were generated using the affected lot. Customers should consult their Laboratory Medical Director if they suspect that patient results were affected. Complete the confirmation of receipt form and return by March 4, 2014. Forward a copy of the Product Correction Notice if the product was distributed outside of your facility. Fax to : 1.888.557.3759 or 1.585.453.4110

Device

Device Recall VITROS Toal T4 Calibrators
  • Model / Serial
    Catalog Number: 139 3396, Lot Number: 1590
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Brazil, Canada, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, Germany, Italy and Spain.
  • Product Description
    VITROS TT4 Calibrator || For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Manufacturer Parent Company (2017)
    The Carlyle Group LP
  • Source
    USFDA