Events

Recall of S/P Orange

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

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
    48739
  • Event Risk Class
    Class 2
  • Event Number
    Z-0278-2009
  • Event Initiated Date
    2008-04-23
  • Event Date Posted
    2008-11-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72032
  • 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
    Glucose Tolerance Drink - Product Code MRV
  • Reason
    Beverage may contain glass particles.
  • Action
    The recalling firm notified distribution centers by letter dated 04/23/08 and advised of a single report of glass found in a bottle. The notifications further advised distributors to quarantine referenced product, notify their customers and return the enclosed reply form. Distributors were requested to return or destroy product for replacement. Please contact NERL Diagnostics, LLC at 1-401-824-2046 for assistance.

Device

S/P Orange
  • Model / Serial
    lot 4067, Exp 12-2009
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    S/P¿ Orange 50g Glucose Tolerance Beverage, 10 oz glass bottles, 12 bottles/case, labeled in part ***Cardinal Health McGaw Park, IL 60085-6787 USA*** For prescription use only. Product is used in support of diagnostics testing for hyperglycemia and hypoglycemia.
  • Manufacturer
    Nerl Diagnostics LLC

Manufacturer

Nerl Diagnostics LLC
  • Manufacturer Address
    Nerl Diagnostics LLC, 3800 Dillon St, Baltimore MD 21224-5248
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA