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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 Stainsee related information
Date Initiated by FirmApril 04, 2011
Date PostedOctober 12, 2011
Recall Status1 Terminated 3 on October 13, 2011
Recall NumberZ-0043-2012
Recall Event ID 58746
Product Classification Stains, hematology - Product Code KQC
ProductHarleco 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 ContactMr. 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
ActionEMD 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 Commerce36 units
DistributionUSA Distribution in the states of PA and NY.
Total Product Life CycleTPLC 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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