Events

Recall of VITROS Clinical Chemistry Products Homocysteine (HCY) Reagent

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
    64874
  • Event Risk Class
    Class 2
  • Event Number
    Z-1556-2013
  • Event Initiated Date
    2013-04-01
  • Event Date Posted
    2013-06-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117225
  • 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
    Urinary homocystine (nonquantitative) test system - Product Code LPS
  • Reason
    The firm is recalling the specific lot due to lower than expected results.
  • Action
    Ortho Clinical Diagnostics sent an "Important Product Correction Notification" letter dated April 1, 2013 to all affected customers. Ortho Clinical Diagnostics recommends that their customers immediately discontinue using and discard all VITROS HCY Reagent remaining in your inventory for the affected lot. They have requested that their customers complete and return the attached Confirmation of Receipt form no later than April 12, 2013. Ortho Clinical Diagnostics requested that these notifications be forwarded to all laboratories and posted beside each VITROS System that utilizes VITROS HCY Reagent within their customers facilities. To place a product order for an alternate lot, please contact Ortho Clinical Diagnostics customer service representatives at 1-800-828-6316. The VITROS Chemistry Products HCY Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure total homocysteine concentration in human serum and plasma.

Device

VITROS Clinical Chemistry Products Homocysteine (HCY) Reagent
  • Model / Serial
    Lot # 1529-17-2636, expiration date 12 June 2013
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AR, AZ, CA, CO, CT, FL, HI, ID, IL, KY, LA, ME, NJ, OK, TN, TX, WA, and WV, and the countries of Colombia, India, Japan, Mexico, Puerto Rico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.
  • Product Description
    VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. || Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
  • 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