Events

Recall of ABX Pentra Micro ALBUMIN 2 CP

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
    80022
  • Event Risk Class
    Class 2
  • Event Number
    Z-2286-2018
  • Event Initiated Date
    2018-04-26
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164230
  • 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
    Reagents for molecular diagnostic test systems - Product Code PFT
  • Reason
    When the abx pentra micro albumin 2 cp (albt2) reagent 2 is sampled and dispensed immediately after an abx pentra creatinine 120 cp (crea3) reagent 2 dispense, the final result of the microalbumin may be elevated more than 10%. this increase may affect serum, plasma and urine sample types.
  • Action
    The firm, Horiba Medical, sent a "FIELD SAFETY NOTICE" dated April 26, 2018 to the customers on the customer list on April 26, 2018. The notice described the product, problem and actions to be taken. The notice directed the consignee to manually program the system to address the issue and the share the information with the laboratory staff and to complete and return the enclosed Acknowledgment Form within 10 days via Fax: (949)753-0533, Email: azita.hedayati@horiba.com or Mail: HORIBA Medical, 9755 Research Dr., Irvine, CA 92618. If you have any questions regarding this Product Corrective Action, please contact your local Horiba Medical representative or our Technical Service Department at 888-903-5001, option 3, option 2.

Device

ABX Pentra Micro ALBUMIN 2 CP
  • Model / Serial
    All lot numbers; Software Version(s): Application versions below (V5.14 & V2.12) for Pentra 400 and Versions below (V1.07) for Pentra C400
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and to countries of: Bulgaria, Burma, Cameroon, Djibouti, France, Gabon, Germany, Italy, Lebanon, Mali, Mauritania, Poland, Portugal, Romania, Saudi Arabia, South Africa and Thailand.
  • Product Description
    ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 || The device is intended for use in conjunction with certain materials to measure a variety of analytes.
  • 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