Recall of Device Recall Appraise Hemoglobin A1c Test

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Heritage Labs International LLC.

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Assay, glycosylated hemoglobin - Product Code LCP
  • Reason
    Kits contain recalled triad alcohol pads.
  • Action
    Heritage Labs sent a Device Notification and Safety Alert letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Heritage Labs sent replacement alcohol prep pads from a different supplier not affected by the recall to user of Heritage Labs kits. Heritage Labs recommended the replacements be on "as needed" basis. Upon opening kit, users should immediately dispose of sealed TRIAD brand alcohol pads. Users are to use the replacement wipes instead of the wipes contained in the kits. For any questions call (888)764-4120.


  • Model / Serial
    All kits containing Triad alcohol prep pads
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution - USA (nationwide) and Germany
  • Product Description
    Appraise Hemoglobin A1c Test , Product K7600, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions. || Blood specimen collection
  • Manufacturer


  • Manufacturer Address
    Heritage Labs International LLC, 560 N Rogers Rd, Olathe KS 66062-1211
  • Source