Events

Recall of Device Recall ABX Pentra 400

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Horiba Instruments 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
    73349
  • Event Risk Class
    Class 2
  • Event Number
    Z-1553-2016
  • Event Initiated Date
    2016-02-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143929
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    Horiba instruments, inc. is recalling abx pentra 400( version 5.0.8 or lower) and pentra c400 (version 1.1.2 or lower) because clinical chemistry analyzer malfunctions when the following certain alarms appear on the system.
  • Action
    HORIBA Medical sent an "Urgent Safety Notice" dated February 19, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A new software version to solve the issue is currently under development; however the firm requests customers use the provided procedure until the new software version is installed on the system, or be extremely vigilant with results of one of the alarms mentioned appears on the system. The letter instructs customers to share the information with laboratory staff and retain the notification as part of laboratory documentation. The letter states it is mandatory for customers to complete and return the enclosed response form within 10 days, in order to verify understanding of it. Any questions or concerns contact the local Horiba Medical representative. For further questions, please call (949) 250-4811.

Device

Device Recall ABX Pentra 400
  • Model / Serial
    All lot/serial #s
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA (nationwide Distribution) to the states of : CA, NY, AL,OK, MS, MD, NV, MN, TX, KY, WV, MI, NY, MT, IL, FL,WA, ID, MO, WY, NJ, VA, KY, GA, PA, TN, MS, KS, AZ, NE, SC, OR, OH, IA, RI, MI and NC.
  • Product Description
    ABX Pentra 400 (version 5.0.8 or lower) || The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.
  • Manufacturer
    Horiba Instruments Inc

Manufacturer

Horiba Instruments Inc
  • Manufacturer Address
    Horiba Instruments Inc, 9755 Research Dr, Irvine CA 92618-4626
  • Manufacturer Parent Company (2017)
    Horiba Ltd.
  • Source
    USFDA