FDA Device Recall Z-0043-2012: EMD Chemicals Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0043-2012.

Recall Res Number

Z-0043-2012

Recalling Firm / Manufacturer

EMD Chemicals Inc.

FEI Number

2244894

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2011-04-04

Date Posted

2011-10-12

Date Terminated

2011-10-13

Product Code

KQC

Event Number

58746

Product Quantity

36 units

Product Description 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.

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

Action Details 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.

Distribution Pattern USA Distribution in the states of PA and NY.

Code Information / Serial Numbers Lot #0197 exp. 31-JUL-2013 and Lot #0236 exp. 31-AUG-2013

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Medical Device Recall: Z-0043-2012

Recall Parameters & Description

Related Establishments / Registrations

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