Events

Recall of ABX PENTRA Magnesium RTU

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Horiba Instruments, Inc dba Horiba Medical.

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
    69105
  • Event Risk Class
    Class 2
  • Event Number
    Z-2692-2014
  • Event Initiated Date
    2014-08-11
  • Event Date Posted
    2014-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-11-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129650
  • 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
    Photometric method, magnesium - Product Code JGJ
  • Reason
    Horiba medical is recalling the abx pentra magnesium rtu reagent because the on-board stability claims has been updated. horiba has updated the abx pentra magnesium rtu package inserts by removing the 7-day on-board stability claim and replacing it with a 1-day on-board stability claim.
  • Action
    Horiba sent an Urgent Safety Notice letter dated August 11, 2014 to all customers running the Magnesium RTU assay on the ABX PENTRA 400 Chemistry analyzers that the On-Board Stability has been updated. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days. For questions call 888-903-5001, ext 4266.

Device

ABX PENTRA Magnesium RTU
  • Model / Serial
    All Lots
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution.
  • Product Description
    ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 || Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemnia (abnormally low plasma levels of magnesium) and hypermagnesemnia (abnormally high plasma levels of magnesium).
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical

Manufacturer

Horiba Instruments, Inc dba Horiba Medical
  • Manufacturer Address
    Horiba Instruments, Inc dba Horiba Medical, 34 Bunsen, Irvine CA 92618-4210
  • Manufacturer Parent Company (2017)
    Horiba Ltd.
  • Source
    USFDA