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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm June 11, 2004
Date Posted October 23, 2004
Recall Status1 Terminated 3 on June 07, 2005
Recall Number Z-0043-05
Recall Event ID 30026
Product Classification System, Multipurpose For In Vitro Coagulation Studies - Product Code JPA
Product The MDA¿ system with MDA¿ Antithrombin III
MDA¿ Heparin
Code Information All product numbers
Recalling Firm/
Manufacturer		 bioMerieux
100 Rodolphe St Bldg 1300
Durham NC 27712-9402
For Additional Information Contact Jocelyn Jennings
919-620-2968
Manufacturer Reason
for Recall		 The firm received complaints regarding an observed bias in percent activity between capped and uncapped specimens.
FDA Determined
Cause 2		 Other
Action Consignees were initially notified by letter on June 11, 2004. A follow up letter was sent to consignees, via Fedex on July 9, 2004.
Distribution Nationwide, Australia, Belgium, Brazil, Canada, China, Germany, Italy, Japan, Taiwan, UK
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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