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U.S. Department of Health and Human Services

Class 3 Device Recall Harleco Giemsa Stain

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  Class 3 Device Recall Harleco Giemsa Stain see related information
Date Initiated by Firm April 04, 2011
Date Posted October 12, 2011
Recall Status1 Terminated 3 on October 13, 2011
Recall Number Z-0043-2012
Recall Event ID 58746
Product Classification Stains, hematology - Product Code KQC
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.
Code Information Lot #0197 exp. 31-JUL-2013 and Lot #0236 exp. 31-AUG-2013
Recalling Firm/
Manufacturer		 EMD Chemicals Inc.
480 S Democrat Rd
Gibbstown NJ 08027-1239
For Additional Information Contact Mr. Joseph P. Schoellkopff
856-423-6300
Manufacturer Reason
for Recall		 Stains may yield lower then expected absorbance levels resulting in under stained hematology specimens.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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