Class 2 Device Recall SickleScan

• Date Initiated by Firm: February 23, 2012
• Date Posted: May 09, 2012
• Recall Status: Terminated on December 13, 2012
• Recall Number: Z-1503-2012
• Recall Event ID: 61384
• 510(K)Number: K860812
• Product Classification: Test, sickle cell - Product Code GHM
• Product: Sickle- Scan Hemoglobin S Cell Reagent Set, Catalog No. 13-2101 100 Tests For the Determination of Hemoglobin S Two bottles Sickle Cell Solubility Buffer, 100 ml , 2 vials Sickle Cell Solubility Powder, Size 100 tests, Store 20-30 C, Distributed by True-Medix Diagnostic Brooklyn, NY 11228, 800-952-3349. For the qualitative determination Hemoglobin S, for in vitro diagnostic use only.
• Code Information: Lot# 1187, expiration date: 7/13 Catalog No.13-2101, Powder Lot # 1171 (part of kit)
• Recalling Firm/ Manufacturer: MichClone Associates, Inc.; 680 Ajax Drive; Madison Heights MI 48071-2414
• For Additional Information Contact: Howard Toben, PhD; 248-583-1150
• Manufacturer Reason for Recall: Two complaints concerning the powder vial included in the 100 test kit has been 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 found no affect on the perf
• FDA Determined Cause: 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: 400 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