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Terminated

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.

FDA Recall Z-0043-2012 · Posted 2011-10-12

Recalling FirmEMD Chemicals Inc.
Recall StatusTerminated
Product CodeKQC
Date Initiated2011-04-04
Date Terminated2011-10-13
Product Quantity36 units

Reason for Recall

Stains may yield lower then expected absorbance levels resulting in under stained hematology specimens.

Firm 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.

Root Cause

Employee error

Distribution Pattern

USA Distribution in the states of PA and NY.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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