Events

Recall of Harleco Giemsa Stain

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by EMD Chemicals 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
    58746
  • Event Risk Class
    Class 3
  • Event Number
    Z-0043-2012
  • Event Initiated Date
    2011-04-04
  • Event Date Posted
    2011-10-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100214
  • 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
    Stains, hematology - Product Code KQC
  • Reason
    Stains may yield lower then expected absorbance levels resulting in under stained hematology specimens.
  • Action
    EMD Chemicals Inc. sent an "IMPORTANT PRODUCT RECALL" letter dated April 4, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. An attached response form is included for customers to complete and return via fax to EMD Chemicals at 856-423-6314. Any questions concerning this recall notice should be directed to EMD Chemicals Technical Service Department at 1-800-222-0342.

Device

Harleco Giemsa Stain
  • Model / Serial
    Lot #0197 exp. 31-JUL-2013 and Lot #0236 exp. 31-AUG-2013
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Distribution in the states of PA and NY.
  • Product Description
    Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-222-0342 || Made in India. || The product is a Class I, IVD dye and chemical stain for use in Hematology.
  • Manufacturer
    EMD Chemicals Inc.

Manufacturer

EMD Chemicals Inc.
  • Manufacturer Address
    EMD Chemicals Inc., 480 S Democrat Rd, Gibbstown NJ 08027-1239
  • Manufacturer Parent Company (2017)
    EMD Chemicals Inc.
  • Source
    USFDA