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U.S. Department of Health and Human Services

Class 2 Device Recall Biotron

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  Class 2 Device Recall Biotron 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-1502-2012
Recall Event ID 61384
510(K)Number K860812  
Product Classification Test, sickle cell - Product Code GHM
Product BioTron Sickle Cell Reagent Set, Screening test for the Presence of Hemoglobin S 2 x 100 ml Sickle Cell Buffer, 2 vials sickle Cell Reagent, Size 100 tests, Store 2-8 C, BioTron Diagnostics Inc, Hemet California, USA .

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.25100, 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 received 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 found no affect on the perf
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 250
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.
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