Events

Recall of Device Recall VITROS Chemistry Products Na Slides

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
    76119
  • Event Risk Class
    Class 2
  • Event Number
    Z-1117-2017
  • Event Initiated Date
    2016-12-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152192
  • 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
    Electrode, ion specific, sodium - Product Code JGS
  • Reason
    There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using vitros na+ slide cartridges warmed at room temperature and loaded onto the analyzer after using the minimum warm up requirements stated in the ifu. if quality control (qc) results are within acceptable limits, reported results are acceptable and were not affected by this issue.
  • Action
    Ortho Clinical Diagnostics sent a Urgent Product Correction Notification dated December 20, 2016, to all affected customers via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who have a VITROS analyzer that can process Na+ Slides to inform them of the potential for biased results on Na+ Slides over the 10 day on-analyzer storage limit for Na+ Slides. Customers were instructed to warm up (equilibrate) all Na Slide cartridges for a minimum of eight hours at room temperature prior to loading them onto the analyzer to help ensure the slides have acceptable performance throughout the 10 day on-analyzer storage limit. Foreign affiliates were informed by email on December 20, 2016, of the issue and instructed to notify their Customers of the issue and the appropriate actions to take. For further questions, please call (585) 453-4224.

Device

Device Recall VITROS Chemistry Products Na Slides
  • Model / Serial
    Generation (GEN): 1 through 6, 30 through 40, 44 through 49 Expiry Dates: 01-JAN-2017 through 01-JUN-2018
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
  • Product Description
    VITROS Na+ Slides, (UPN 10758750004812) || For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 513 Technology Blvd, Rochester NY 14626-3601
  • Manufacturer Parent Company (2017)
    The Carlyle Group LP
  • Source
    USFDA