Events

Recall of Device Recall VITROS Performance Verifier II

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ortho Clinical Diagnostics Inc.

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
    78724
  • Event Risk Class
    Class 3
  • Event Number
    Z-0807-2018
  • Event Initiated Date
    2017-07-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160228
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • Reason
    Vitros performance verifier ii (pvii) lot k4852 does not meet long term stability requirements for the ast analyte (only) when the product is stored refrigerated for up to 6 months.
  • Action
    On July 10, 2017 the firm sent notification letters and an e-communications to their customers. Foreign customers were notified by email. Customers were instructed to complete a response form with the amount of product on hand and to discontinue use of the recalled product. For further questions, please call (585) 453-3452.

Device

Device Recall VITROS Performance Verifier II
  • Model / Serial
    Lot K4852, Expiration 22 Feb 2018
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. || Used as a control for the VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
  • Manufacturer
    Ortho Clinical Diagnostics Inc

Manufacturer

Ortho Clinical Diagnostics Inc
  • Manufacturer Address
    Ortho Clinical Diagnostics Inc, 1001 US Highway 202, Raritan NJ 08869-1424
  • Manufacturer Parent Company (2017)
    The Carlyle Group LP
  • Source
    USFDA