Class 3 Device Recall Simplastin L

• Date Initiated by Firm: July 31, 2003
• Date Posted: October 15, 2003
• Recall Status: Terminated on May 18, 2004
• Recall Number: Z-1238-03
• Recall Event ID: 27008
• Product Classification: Test, Time, Prothrombin - Product Code GJS
• Product: Simplastin L, Prothrombin Time test, 10 vials (20 ml each), Product Number 259553, bioMerieux,
• Code Information: Product #259553, Lot #161642, 161643 and 161690.
• FEI Number: 3002769706
• Recalling Firm/ Manufacturer: bioMerieux; 100 Rodolphe Street; Building 1300; Durham NC 27712
• For Additional Information Contact: Jocelyn Jennings; 919-920-2968
• Manufacturer Reason for Recall: Complaints of prolonged clot times.
• FDA Determined Cause: Other
• Action: Consignees were notified via letter on July 31, 2003. The were advised to check remaining inventory and destroy any remaining material of the affected lot numbers. A Customer Response form was attached.
• Quantity in Commerce: 689 units
• Distribution: The product was distributed to hospitals and distributors located nationwide, Brazil, Canada, China, and Japan.
• 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.