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U.S. Department of Health and Human Services

Class 2 Device Recall Xmatrx FISH Automated Staining System

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  Class 2 Device Recall Xmatrx FISH Automated Staining System see related information
Date Initiated by Firm January 24, 2008
Date Posted August 22, 2008
Recall Status1 Terminated 3 on January 08, 2011
Recall Number Z-1471-2008
Recall Event ID 46903
Product Classification Automated slide staining system - Product Code KEY
Product Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number AS4010B
Code Information Serial numbers AS40211, AS40226, AS40230, AS40231, AS40232, AS40233, AS40234, AS40235, AS40236, AS40237. These serial numbers encompass ALL products distributed.
Recalling Firm/
Manufacturer		 Biogenex Laboratories
4600 Norris Canyon Road
San Ramon CA 94583-1320
For Additional Information Contact
925-275-0550
Manufacturer Reason
for Recall		 Bulk reagent dispensing mechanism may break resulting in reagent spill and possible exposure to chemicals.
FDA Determined
Cause 2		 Component design/selection
Action The firm initiated written notification on 01/24/2008. The firm has asked its consignee to inform its consignees of the recall.
Quantity in Commerce 10 units distributed.
Distribution Product was distributed to a single distributor, which further distributed the product.
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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