Class 1 Device Recall

• Date Initiated by Firm: March 07, 2005
• Date Posted: May 18, 2005
• Recall Status: Terminated 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 HO, ( and 6 ml HO) 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/ Manufacturer: BIOMERIEUX, INC.; 100 Rodolphe St; Durham NC 27712-9402
• For Additional Information Contact: John Cusack, Sr.; 919-620-2803
• 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: Other
• 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