Events

Recall of Vacuette 4ml FX Sodium Fluoride / Potassium Oxalate tube

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Greiner Bio-One North America, 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
    74002
  • Event Risk Class
    Class 2
  • Event Number
    Z-1923-2016
  • Event Initiated Date
    2016-04-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145883
  • 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
    Tubes, vials, systems, serum separators, blood collection - Product Code JKA
  • Reason
    The 4 ml fx sodium fluoride/potassium oxalate tube may have no or low additive (sodium fluoride and potassium oxalate), which can effect analytical results for glucose and lactate.
  • Action
    Greiner Bio-One North America, Inc. sent an Urgent Product Recall letter dated April 26, 2016, to all affected consignees. The letter requested that they stop distribution of the product and to provide Greiner with a list of their sub-accounts. The letter included a Product Disposition/Site Confirmation form which is to be returned to Greiner Bio-one. Consignees with questions were instructed to call 800-515-8112. For questions regarding this recall call 704-261-7823.

Device

Vacuette 4ml FX Sodium Fluoride / Potassium Oxalate tube
  • Model / Serial
    Lot A151137L
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to CA, FL, IL, KY, NY, PA, VA and Puerto Rico
  • Product Description
    4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 || VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an anticoagulant, potassium oxalate. The product is suitable for the analysis of blood glucose and lactate
  • Manufacturer
    Greiner Bio-One North America, Inc.

Manufacturer

Greiner Bio-One North America, Inc.
  • Manufacturer Address
    Greiner Bio-One North America, Inc., 4238 Capital Dr, Monroe NC 28110-7681
  • Manufacturer Parent Company (2017)
    Greiner Holding Ag
  • Source
    USFDA