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U.S. Department of Health and Human Services

Class 2 Device Recall Xmatrx FISH

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  Class 2 Device Recall Xmatrx FISH see related information
Date Initiated by Firm January 23, 2009
Date Posted March 08, 2010
Recall Status1 Terminated 3 on December 02, 2010
Recall Number Z-1016-2010
Recall Event ID 51296
Product Classification Stainer, Tissue, Automated - Product Code KEY
Product Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model Number/Catalog Number: AS4010B;

The product is manufactured by: BioGenex Laboratories, Inc. 4600 Norris Canyon Road San Ramon, CA 94583 and Distributed by: Abbott Molecular, 1300 E. Touhy Ave - 2E, Des Plaines, IL 60018

Xmatrx Automated Staining System is intended for in vitro diagnostic use. It is suitable for fluorescent hybridization (FISH) applications.
Code Information Serial Numbers: AS40211, AS40226, AS40230, AS40231, AS40232, AS40233, AS40234, AS40235, AS40236, and AS40237
Recalling Firm/
Manufacturer		 Biogenex Laboratories
4600 Norris Canyon Road
San Ramon CA 94583-1320
For Additional Information Contact Jintao Chen, Ph.D.
925-275-0550
Manufacturer Reason
for Recall		 Under certain conditions, product system failure has the potential to cause operator injury due to splash of Hemo-De solution.
FDA Determined
Cause 2		 Device Design
Action On 1/23/09, the firm issued an Advisory Notice to all its direct consignees, informing them of the affected product and providing instructions on the recall. Please contact BioGenex Technical Support at 1-800-421-4149 for any assistance you may need.
Quantity in Commerce 12 units
Distribution The firm distributed the product to one (1) distributor as a consignee of our product. The firm indicated that no customer has received the product directly from BioGenex, due to the fact that the product is exclusive distributed by Abbott Molecular.
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.
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