Events

Recall of MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for SelfTesting & MultiPa

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nipro Diagnostics, 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
    67152
  • Event Risk Class
    Class 2
  • Event Number
    Z-0910-2014
  • Event Initiated Date
    2013-10-02
  • Event Date Posted
    2014-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124800
  • 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
    Manufactured with an incorrect factory set unit of measure.
  • Action
    Nipro Diagnostics sent an Urgent Medical Device Voluntary Recall letter dated December 31, 2013 to all affected customers. The customers were instructed to do the following: 1) Screen their inventory immediately for any of the serial numbers listed on the back of the products. 2) If they have any of the affected products, return the product by contacting Stericycle at 1-866-236-4518. 3) Complete and return the enclosed response form via fax at 1-888-358-7294. Customers with questions were instructed to call Stericycle at 1-866-236-4518. For questions regarding this recall call 954-677-9201.

Device

MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for SelfTesting & MultiPa
  • Model / Serial
    Finished Goods: KJ0731; Lot Numbers: KK0964, KL01213, KL01233-3TI, KL0267-10, KL0381-14, KL0637-2TI, KL0716TI, KL0860TI, KP0074TI.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide, HI and Puerto Rico and Internationally to Canada, European Union, Jamaica, Suriname, Trinidad and Tobago, Kazakhastan, Russian, Turkey, Australia, Bangladesh, Pakistan, Cambodia, Laos, Myanmar, Thailand, Vietnam, and India.
  • Product Description
    MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. || Is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm.
  • Manufacturer
    Nipro Diagnostics, Inc.

Manufacturer

Nipro Diagnostics, Inc.
  • Manufacturer Address
    Nipro Diagnostics, Inc., 2400 NW 55th Ct, Ft Lauderdale FL 33309-2672
  • Manufacturer Parent Company (2017)
    Nipro Corporation
  • Source
    USFDA