Events

Recall of Device Recall VITROS CHEMISTRY PRODUCTS TRIG Slides

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
    69791
  • Event Risk Class
    Class 2
  • Event Number
    Z-0848-2015
  • Event Initiated Date
    2014-11-06
  • Event Date Posted
    2014-12-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131547
  • 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
    Lipase hydrolysis/glycerol kinase enzyme, triglycerides - Product Code CDT
  • Reason
    Potential for biased results using the specific lot of vitros chemistry products trig slides.
  • Action
    Ortho Clinical Diagnostics sent an Urgent Product Correction Notification dated November 6, 2014, via FedEx overnight courierand/or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to all affected customers. The letter identified the product, the problem, and the acton to be taken by the customer. The letter informed the customers of the issue and advise them to discontinue use of the affected lot and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. For additional questions, please contact OCD's Customer Technical Services at 1-800-421-3311. For questions regarding this recall call 908-218-8776.

Device

Device Recall VITROS CHEMISTRY PRODUCTS TRIG Slides
  • Model / Serial
    Lot 0704-3318-4774 (expiry date 01 Dec 2015)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
  • Product Description
    VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD || For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 513 Technology Blvd, Rochester NY 14626-3601
  • Manufacturer Parent Company (2017)
    The Carlyle Group LP
  • Source
    USFDA