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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJune 11, 2004
Date PostedOctober 23, 2004
Recall Status1 Terminated 3 on June 07, 2005
Recall NumberZ-0043-05
Recall Event ID 30026
Product Classification System, Multipurpose For In Vitro Coagulation Studies - Product Code JPA
ProductThe 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 ContactJocelyn 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
ActionConsignees were initially notified by letter on June 11, 2004. A follow up letter was sent to consignees, via Fedex on July 9, 2004.
DistributionNationwide, Australia, Belgium, Brazil, Canada, China, Germany, Italy, Japan, Taiwan, UK
Total Product Life CycleTPLC 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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