Recall Z-0043-2012 ยท KQC Stains, Hematology
EMD Chemicals Inc.
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.
| Date | Oct 12, 2011 (initiated Apr 4, 2011) |
| Status | Terminated |
| Reason | Stains may yield lower then expected absorbance levels resulting in under stained hematology specimens. |
| 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 | 36 units |
| Distribution | USA Distribution in the states of PA and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.