Events

Recall of VITROS VALP 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
    31942
  • Event Risk Class
    Class 2
  • Event Number
    Z-0866-05
  • Event Initiated Date
    2005-04-18
  • Event Date Posted
    2005-06-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38786
  • 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, Valproic Acid - Product Code LEG
  • Reason
    Negatively biased results may be observed when the reagent is stored on the vitros 5,1fs chemistry system for less than seven days.
  • Action
    Letters dated 4/18/2005 with instructions to process a mid-level QC fluid every eight hours when processing patient samples for valproic acid. Replacement product to be shipped as soon as available.

Device

VITROS VALP Reagent
  • Model / Serial
    01-5871, Exp. 31Jan06
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    37 U.S. consignees nationwide. Ortho-Clinical foreign affiliates in England, France and Spain.
  • Product Description
    VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Responsible firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, N.Y. 14626.
  • 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