Events

Recall of Device Recall VITROS Valproic Acid (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
    60800
  • Event Risk Class
    Class 2
  • Event Number
    Z-0984-2012
  • Event Initiated Date
    2011-05-10
  • Event Date Posted
    2012-02-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106564
  • 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
    Results using vitros¿ chemistry products valp reagent were negatively biased compared to other manufacturers. ocd confirmed that patient results were also affected by this issue.
  • Action
    All domestic end-user consignees were initially sent "Important Product Correction Notification" recall communications (dated 5/10/11) by Federal Express overnight mail on 5/10/11. The letters informed users of the issue, and advised them to discontinue using their VITROS VALP reagent until adjusted calibrator values are provided for GEN 14 of VITROS VALP Reagent. The adjusted calibrator values for VITROS VALP Reagent were sent to customers via Assay Data Disk (ADD) Data Release Version (DRV) 5632. Customers were to refer to the Technical Support Communication for details. Users were to confirm receipt of the notice by completing and returning the Fax Reply Form - Confirmation; confirm that all customers or distributors were informed of the issue and instructed to discontinue use of affected product; and lastly confirm that all customers or distributors were sent adjusted calibrator values.

Device

Device Recall VITROS Valproic Acid (VALP) Reagent
  • Model / Serial
    Reagent Lots from Generation (GEN) 14: 1511-14-9637 (exp. 6/30/11), 1511-14-9776 (exp. 9/30/11), 1511-14-9894 (exp. 11/30/11), 1511-14-1094 (exp. 1/31/12), and 1511-14-1230 (exp. 4/30/12).
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
  • Product Description
    VITROS¿ Valproic Acid (VALP) Reagent, REF/Catalog No. 6801710 --- Ortho- Clinical Diagnostics Rochester, NY USA -- Ortho- Clinical Diagnostics High Wycombe, UK --- An in vitro diagnostic. || For in vitro diagnostic use only. Used to quantitatively measure valproic acid (VALP) concentration in human serum and plasma.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
  • Source
    USFDA