Events

Recall of Device Recall Nova StatStrip Glucose Test Strips

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nova Biomedical Corporation.

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
    64638
  • Event Risk Class
    Class 2
  • Event Number
    Z-1153-2013
  • Event Initiated Date
    2013-02-25
  • Event Date Posted
    2013-04-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116692
  • 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 oxidase, glucose - Product Code CGA
  • Reason
    Glucose test strips reports no result message when tested.
  • Action
    The firm, Nova Biomedical, sent an "Urgent Field Safety Notice 01-13SS" dated March 18, 2013 and US customers notification by phone contact and to the International customers including a Faxback Form to be communicated to and sent to Nova Biomedical Subsidiary by two methods of delivery (Email and Phone Call). The customers were instructed to INVALIDATE the Nova StatStrip Glucose Test Strip lots indicated in the list on all StatStrip meters within your institute; REPLACE all Nova StatStrip Glucose Test Strips from the indicated lots with replacement test strips provided by Nova; REMOVE all unused boxes of the Nova StatStrip Glucose Test Strip lots indicated from all locations within your institute; RETURN all unused boxes of the Nova StatStrip Glucose Test Strips lots indicated to Nova Biomedical U.K. or your local Nova distributor following the country specific instructions provided by your authorized Nova representative, and complete and return the Fax-Back Form via email or FAX to your Regional Service Manager at 781-8914806. On April 08, 2013, the firm expanded the recall notification to include one additional test strip lot #0313021309 which was shipped under two catalog numbers(Catalog # 42214 and Catalog# 51493). US Notification by phone contact with key customer contact facilitated by Senior Manger of Technical Support Services. International - Field Safety Notice and Faxback Form is being communicated to and sent to Nova Biomedical Subsidiary by two methods of delivery (Email and Phone Call). Questions regarding this notice should be directed to the following Nova Biomedical EU Authorized Representative at: Nova Biomedical Innovation House, Aston Lane South Runcorn,WA7 3FY Telephone: + 44 1244 287087 Email: Europe@novabiomedical.co.uk. or US at (781) 894-0800.

Device

Device Recall Nova StatStrip Glucose Test Strips
  • Model / Serial
    Lot 0312349249, Expires 12/31/2014 and Lot 0312361309, Expires 06/30/2015  Expanded recall: Lot 0313021309, Expires 07/31/2015
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: CA, IL, KY,NY, WV and countries of: United Kingdom and Italy.
  • Product Description
    Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) || Catalog # 42214
  • Manufacturer
    Nova Biomedical Corporation

Manufacturer

Nova Biomedical Corporation
  • Manufacturer Address
    Nova Biomedical Corporation, 200 Prospect St, Waltham MA 02453
  • Manufacturer Parent Company (2017)
    Nova Biomedical Corporation
  • Source
    USFDA