Events

Recall of Device Recall Vitros Universal Wash 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
    25394
  • Event Risk Class
    Class 3
  • Event Number
    Z-0558-03
  • Event Initiated Date
    2003-01-10
  • Event Date Posted
    2003-02-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-06-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25733
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Label printing irregularities on cartons and/or bottles.
  • Action
    Letters dated 1/10/03 sent U.S. Mail instructing customers to examine inventory and discard bottles or cartons with missing or illegible print.

Device

Device Recall Vitros Universal Wash Reagent
  • Model / Serial
    Lot 5003, Exp. 12 September 2003
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribution
    Product was shipped to medical facilities nationwide. There were 6 federal government consignees shipped product under government contract #V797-6565A. No product was shipped outside the U.S.
  • Product Description
    Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic use only. The product is sold in cartons containing 2 bottles (5 liters each). CAT 838 9793
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14650-0881
  • Source
    USFDA