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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 August 20, 2004
Date Posted October 28, 2004
Recall Status1 Terminated 3 on June 09, 2005
Recall Number Z-0053-05
Recall Event ID 30013
510(K)Number K802117  
Product Classification Test, Thrombin Time - Product Code GJA
Product MDA¿ Fibriquik¿, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969
Code Information Product number 252560, Lot number 505046
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		 Complaints were received from the field regarding prolonged clot times, high control values and erratic results.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on 8/20/2004.
Quantity in Commerce 1165 units
Distribution Nationwide, Australia, Brazil, Canada, China, Japan, Laos, Philippines, 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.
510(K) Database 510(K)s with Product Code = GJA and Original Applicant = GENERAL DIAGNOSTICS
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