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U.S. Department of Health and Human Services

Class 2 Device Recall Sickle Heme

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  Class 2 Device Recall Sickle Heme see related information
Date Initiated by Firm February 23, 2012
Date Posted May 09, 2012
Recall Status1 Terminated 3 on December 13, 2012
Recall Number Z-1501-2012
Recall Event ID 61384
510(K)Number K860812  
Product Classification Test, sickle cell - Product Code GHM
Product Sickle Heme, Hemoglobin S Solubility For Qualitative Determination of Hemoglobin S Test; ,100 Test Kit Product, No MCA 100, Contents: Two bottles of Sickle Cell Buffer, Two Bottles of Sickle Cell Powder; One Line Scale Two Dispensing Closures; For Invitor Diagnostics Use, Store at Room Temperature, Michclone Associates, Madison Heights, MI 48071.

For the qualitative determination of positive or negative Sickle Cell Anemia present in Hemoglobin , for in vitro diagnostic use only.

Code Information Lot# 1187, expiration date: 7/13  Catalog No.MCA-IOO, MHK 110A Powder Lot # 1171 (part of kit) 
Recalling Firm/
MichClone Associates, Inc.
680 Ajax Drive
Madison Heights MI 48071-2414
For Additional Information Contact Howard Toben, PhD
Manufacturer Reason
for Recall
Michclone Associate's has received two complaints concerning the powder vial included in the 100 test kit observed producing pressure while sealed. When the powders are opened, the pressure from within the vial releases a small amount of powder into the air. This powder. if released near the face and inhaled can cause minor irritation resulting in sneezing and nasal congestion. Investigation f
FDA Determined
Cause 2
Nonconforming Material/Component
Action Michclone Associates, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 15, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to identify affected lots, notify sub accounts, and complete and return the response form to arrange return of unused product and replacement . Forms can be returned by FAX 248(307)-9498, mail: Michclone Associates Inc. 680 Ajax Drive, Madison Heights, MI 48118 or Email: toben@greatlakesdiag.com. Questions and concerns should be addressed to Technical Support Department at 248-307-9494.
Quantity in Commerce 120 kits
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GHM and Original Applicant = MICHCLONE ASSOCIATES, INC.