Events

Recall of Device Recall Pointe Scientific Iron (Ferrozine) Reagent Set

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
    53872
  • Event Risk Class
    Class 2
  • Event Number
    Z-0901-2010
  • Event Initiated Date
    2009-11-16
  • Event Date Posted
    2010-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86770
  • 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
    Photo Metric Method, Iron (non-heme) - Product Code JIY
  • Reason
    Turbidity formation could occur, resulting in invalid test results being reported out.
  • Action
    Consignees were notified by recall letter dated 11/16/09 and instructed to discard any remaining product. Please call 1-800-757-5313 if you have questions.

Device

Device Recall Pointe Scientific Iron (Ferrozine) Reagent Set
  • Model / Serial
    All lot numbers containing the numbers 735401 or 816501.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Austria, Bolivia, Canada, Cyprus, Egypt, Ghana, Greece, Guyana, India, Indonesia, Israel, Jordan, Kenya, Korea, Lebanon, Macedonia, Malaysia, Mexico, Nicaragua, Nigeria, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Trinidad, Turkey, Ukraine and Venezuela.
  • Product Description
    Pointe Scientific Iron (Ferrozine) Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #s: HI704-300, HI904-1200, HI904-498, HI904-600, HI904-SAM-911, HI904-SAM-917 and 12-HI904-144. || Clinical chemistry reagent for the quantitative determination of iron in serum.
  • 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