Recall Z-0043-2012
EMD Chemicals Inc. · initiated April 4, 2011
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.
Codes / lots: Lot #0197 exp. 31-JUL-2013 and Lot #0236 exp. 31-AUG-2013
Reason for recall
Stains may yield lower then expected absorbance levels resulting in under stained hematology specimens.
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-0043-2012
- Initiated
- April 4, 2011
- Posted by FDA
- October 12, 2011
- Terminated
- October 13, 2011
- Product code
- KQC – Stains, Hematology
- Quantity
- 36 units
- Distribution
- USA Distribution in the states of PA and NY.
- Recalling firm
- EMD Chemicals Inc., Gibbstown, NJ