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U.S. Department of Health and Human Services

Class 1 Device Recall

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  Class 1 Device Recall see related information
Date Initiated by Firm March 07, 2005
Date Posted May 18, 2005
Recall Status1 Terminated 3 on October 16, 2006
Recall Number Z-0843-05
Recall Event ID 31482
510(K)Number K974566  
Product Classification Test, Time, Prothrombin - Product Code GJS
Product Simplastin HTF¿ Reagents, 20ml H¿O, ( and 6 ml H¿O) bioMerieux, Inc., Durham, NC 27704
Code Information Product numbers 259846, 259847, Lot numbers: 161849, 161800 and 161798. Recall Expanded (03/23/2005) to include these additional lot numbers: 161655, 161710, 161741, 161738, 161742, 1621739, 161743, 161740, 161764, 161763, 161797 and 161799.
Recalling Firm/
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact John Cusack, Sr.
Manufacturer Reason
for Recall
The ISI labeling for Simplastin¿ HTF on the Coag-a-Mate¿ MAX and Thrombolyzer instrument platforms is not correct. The Simplastin HTF ISI assignment was mis-assigned and the published values are higher than expected for the listed instrument platforms.
FDA Determined
Cause 2
Action Consignees were notified by letter on/about March 7, 2005.
Quantity in Commerce 19748 kits
Distribution Nationwide, Canada, Colombia, India, Philippines, Spain, Thailand
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 = GJS and Original Applicant = ORGANON TEKNIKA CORP.