Events

Recall of Device Recall UniStrip1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Unistrip Technologies 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
    69856
  • Event Risk Class
    Class 2
  • Event Number
    Z-0855-2015
  • Event Initiated Date
    2014-11-20
  • Event Date Posted
    2014-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131711
  • 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
    System, test, blood glucose, over the counter - Product Code NBW
  • Reason
    Failure to submit a 510(k) for device labeling changes.
  • Action
    UniStrip Technologies sent an Urgent Device Recall letter dated November 20, 2014, to all affected customers. They were instructed to immediately inform any of their retail accounts of the recall and have them return any of the recalled product to the distributor. The product is then to be returned to Unistrip Technologies. A reply form was included to be completed by the retail accounts and returned to the distributor who would in turn return the form to Unistrip Technologies to track returns. If you have any further questions, please call 1-866-861-8066.

Device

Device Recall UniStrip1
  • Model / Serial
    U14030713, 814031313, U140312323, and U14031413.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of FL and OH.
  • Product Description
    UniStrip1, Blood Glucose Test Strips, 50 count box. || The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
  • Manufacturer
    Unistrip Technologies LLC

Manufacturer

Unistrip Technologies LLC
  • Manufacturer Address
    Unistrip Technologies LLC, 301 Mccullough Dr, Suite 400, Charlotte NC 28262-3310
  • Manufacturer Parent Company (2017)
    Unistrip Technologies Llc
  • Source
    USFDA