Events

Recall of HDL Cholesterol Reagent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stanbio Laboratory, 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
    36436
  • Event Risk Class
    Class 2
  • Event Number
    Z-0074-2007
  • Event Initiated Date
    2006-09-18
  • Event Date Posted
    2006-11-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48654
  • 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
    in vitro diagnostic - Product Code LBR
  • Reason
    Unexpected changes in qc and proficiency results due to qc and proficiency material matrix.
  • Action
    Firm notified consignees via letter on 09/20/06.

Device

HDL Cholesterol Reagent
  • Model / Serial
    Control #05276CE; kit contains Lot #23651 and Lot #23652; (Pointe Scientific Lot #523002).
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Korea, Thailand, Venezuela and Mexico.
  • Product Description
    Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-040; test kit contains 1/30mL container of Direct HDL-Cholesterol Buffer (R1) and 1/10mL container of Direct HDL-Cholesterol Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX.
  • Manufacturer
    Stanbio Laboratory, Inc

Manufacturer

Stanbio Laboratory, Inc
  • Manufacturer Address
    Stanbio Laboratory, Inc, 1261 N Main St, Boerne TX 78006-3014
  • Source
    USFDA