Events

Recall of Device Recall HITACHI DIRECT AND HITACHI TOTAL BILIRUBIN REAGENT

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pointe Scientific, 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
    51042
  • Event Risk Class
    Class 3
  • Event Number
    Z-1202-2009
  • Event Initiated Date
    2009-02-02
  • Event Date Posted
    2009-04-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=78238
  • 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
    Diazo colorimetry, bilirubin - Product Code CIG
  • Reason
    The product performance fails due to precipitation of the r2 component.
  • Action
    Consignees were notified by "Urgent: Medical Device Recall" letter dated February 2, 2009 and mailed on February 6, 2009, and instructed to conduct the recall to the retail level if they had further distributed the product, to destroy any stocks on hand, and to complete and return the "Recall Return Response Form" via mail, e-mail, or fax (734-483-1592) to Point Scientific, Inc. Direct questions to the firm's Technical Support Department at 1-800-757-5313 or 1-734-487-8300.

Device

Device Recall HITACHI DIRECT AND HITACHI TOTAL BILIRUBIN REAGENT
  • Model / Serial
    HB936-120, Lot Number: 731801, exp. 11/2011 and HB936-294, Lot Number: 817103, exp. 5/2012.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Chile and Mexico.
  • Product Description
    Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. || The device intended use is a clinical chemistry reagent for the in vitro, quantitative determination of direct bilirubin in serum on Hitachi analyzers.
  • Manufacturer
    Pointe Scientific, Inc.

Manufacturer

Pointe Scientific, Inc.
  • Manufacturer Address
    Pointe Scientific, Inc., 5449 Research Dr, Canton MI 48188
  • Manufacturer Parent Company (2017)
    MedTest Holdings
  • Source
    USFDA