Events

Recall of Device Recall Pointe Scientific Uric Acid (Liquid) 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
    54112
  • Event Risk Class
    Class 2
  • Event Number
    Z-0913-2010
  • Event Initiated Date
    2009-12-01
  • Event Date Posted
    2010-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87505
  • 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
    Acid, uric, uricase (colorimetric) - Product Code KNK
  • Reason
    A process deviation occurred during the production of the r1 component which may affect its performance.
  • Action
    Pointe Scientific, Inc. issued an "Urgent: Medical Device Recall" notification dated December 1, 2009. Consignees were instructed to examine their inventory for the affected product and discard the affected product immediately. For further information, contact Pointe Scientific, Inc. Technical Support at 1-800-757-5313 or 1-734-487-8300.

Device

Device Recall Pointe Scientific Uric Acid (Liquid) Reagent Set
  • Model / Serial
    All lot numbers containing the numbers 918301; exp. 2011-01.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States (California, Florida, Kentucky, Michigan, Ohio, Oklahoma and Virginia), Chile and Malaysia.
  • Product Description
    Pointe Scientific Liquid Uric Acid (R1) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU482-R1. || For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only.
  • 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