Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-2

FDA device recall Z-0043-2012 · posted 2011-10-12 · Terminated

Recall details

Recalling firm

EMD Chemicals Inc.

Reason for recall

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

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.

Root cause

Employee error

Status

Terminated

Product code

KQC

Quantity affected

36 units

Distribution

USA Distribution in the states of PA and NY.

Date initiated

2011-04-04

Date posted

2011-10-12

Date terminated

2011-10-13

Location

Gibbstown, NJ