Events

Recall of Device Recall VITROS

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
    61222
  • Event Risk Class
    Class 2
  • Event Number
    Z-1316-2012
  • Event Initiated Date
    2012-02-02
  • Event Date Posted
    2012-03-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107602
  • 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
    Ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl - Product Code LBS
  • Reason
    Ortho clinical diagnostics (ocd) has revised the vitros dhdl slides instructions for use (ifu) and removed edta plasma as a recommended sample type.
  • Action
    Ortho Clinical Diagnostics sent an Important Product Information letter dated February 2, 2012, to all affected customers via Federal Express overnight mail. The letter informed customers of the issue, notifying them of the removal of EDTA plasma as a recommended sample type and providing the revised VITROS¿ dHDL Slides Instructions for Use. J&J; Foreign affiliate consignees were notified by email informing them of the issue on 02 February 2012. Customers were instructed to replace the current pages in their VITROS Chemistry Products Instructions for Use Manual with the updated instructions for Use and Table of Contents. Customers were asked to return the enclosed Confirmation of Receipt form regardless of whether their laboratory uses the affected product. For any questions regarding this recall call 1-800-421-3311.

Device

Device Recall VITROS
  • Model / Serial
    all lots
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    VITROS Chemistry Products --- dHDL Slides --- Ortho Clinical Diagnostics, a Johnson&Johnson; company --- [Mfg Symbol] Ortho-Clinical Diagnostics, Inc., Rochester, NY USA --- VITROS dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS Chemistry and Integrated Systems. --- Product codes: 6801895 (60 slide count); 6802469 (18 slide count) --- indicated to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS Chemistry and Integrated Systems.
  • 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