Events

Recall of Device Recall ABX PENTRA N Control,

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
    66912
  • Event Risk Class
    Class 2
  • Event Number
    Z-0904-2014
  • Event Initiated Date
    2013-11-21
  • Event Date Posted
    2014-01-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124157
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • Reason
    Horiba medical is recalling the abx pentra n control because it has been updated to include a revised target value assignment for potassium.
  • Action
    Horiba sent an customer notification letter dated November 32, 2013, to all affected customers. The letter was sent via email to all customers who purchased the ABX PENTRA 400. HORIBA Medical is informing all ABX PENTRA N Control customers running the Potassium-E assay on the ABX PENTRA 400 with I.S.E. Module that the Target Value and Target Range for Potassium has been updated. The letter informs the customers of the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days by fax (949) 453-0600 Customers with questions are instructed to contact their local HORIBA Medical representative. For further questions please call (949) 453-0500 X 208

Device

Device Recall ABX PENTRA N Control,
  • Model / Serial
    Lot No. 1300801
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide)
  • Product Description
    ABX PENTRA N Control, Model No. A11A01653 || The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.
  • 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