Z-0043-2012

Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ...

Name: Z-0043-2012 Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ...
Creator: EMD Chemicals Inc.
Published: 2011-04-04
License: https://open.fda.gov/license/

EMD Millipore Corporation / initiated 2011-04-04 / Terminated / root cause: manufacturing process

FDA source

EMD Chemicals Inc. began a recall of 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... on 2011-04-04. The reason FDA records is "Stains may yield lower then expected absorbance levels resulting in under stained hematology specimens". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0043-2012
Status: Terminated
Initiated: 2011-04-04
Posted: 2011-10-12
Terminated: 2011-10-13
Recalling firm: EMD Millipore Corporation
Product: 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.
Product code: KQC Stains, Hematology
Reason for recall: Stains may yield lower then expected absorbance levels resulting in under stained hematology specimens.
Root cause tag: manufacturing process
FDA root cause: Employee error
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.
Quantity in commerce: 36 units
Distribution: USA Distribution in the states of PA and NY.
Product codes and lots: Lot #0197 exp. 31-JUL-2013 and Lot #0236 exp. 31-AUG-2013

Product code KQC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)