Events

Recall of Nova StatStrip/StatSensor Hospital Blood Glucose Meter

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
    66398
  • Event Risk Class
    Class 2
  • Event Number
    Z-0650-2014
  • Event Initiated Date
    2013-10-10
  • Event Date Posted
    2014-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122250
  • 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
    Revised battery instructions for removal and expiration date due to battery swelling and cell leakage.
  • Action
    On November 18, 2013, an URGENT Field Correction Letter was sent to all StatStrip Glucose Hospital meter, StatStrip Lactate Hospital Meter and StatSensor Creatinine Hospital Meter customers via email to the Point of Care Coordinator to alert users that lithium batteries that are utilized beyond their intended useful life may swell and/or crack posing a potential safety hazard. In some cases, the swelling may potentially cause the battery door on the meter to dislodge and render the meter inoperable.

Device

Nova StatStrip/StatSensor Hospital Blood Glucose Meter
  • Model / Serial
    All serial numbers
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, || Rechargeable Lithium Batteries || Single: 46626; 4 Pack: 46827; 5 Pack: 50436. || For Point-Of-Care usage in the quantitative determination of Glucose in whole blood.
  • 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