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U.S. Department of Health and Human Services

Class 2 Device Recall Simplastin Excel S

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  Class 2 Device Recall Simplastin Excel S see related information
Date Initiated by Firm December 23, 2002
Date Posted March 06, 2003
Recall Status1 Terminated 3 on January 21, 2004
Recall Number Z-0628-03
Recall Event ID 25366
510(K)Number K882214  
Product Classification Test, Time, Prothrombin - Product Code GJS
Product BIOMERIEUX, Thromboplastin Reagent, Simplastin Excel S, 6 ml Diluent, bioMerieux, Inc., Durham, NC 27704
Code Information Product# 252182- Lot #161553, 161580, 161581 and 161661. Additional Catalog number: 252183, Lot number: 161662. Additional lot numbers recalled 3/19 & 31/2003: Lot #161639, 161664, 161716 and 161717. Recall expanded on 5/30/2003 to include the balance of the lot number produced under previous manufacturing practice. Product Number 252182 (6 ml), Lot number 161506; Prduct Number 252183 (20 ml), Lot Number 161503, 161504, 161554, 161582 and 161640.
Recalling Firm/
Manufacturer		 Biomerieux, Inc.
100 Rodolphe Street
Durham NC 27712
For Additional Information Contact
800-682-2666
Manufacturer Reason
for Recall		 Vial to vial variability which can result in prolonged clot times.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter via regular mail on December 23, 2002. They were advised to cease using the product, pull affected lot numbers, destroy the material and contact bioMerieux for replacement. Expanded recall 3/18/2003, consignees were notified by letter on March 19th , and March 31, 2003. Consignees were advised to stop using the affected lot numbers, destroy the remaining material in inventory and to contact their local bioMerieux Customer Service representative for replacement.
Quantity in Commerce 4276 kits of lot #161553, 4275 kits of lot #161580, 4279 kits of lot #161581 and 4300 kits of lot 161661. Additional 2,280 kits of lot 161662.
Distribution CA, CO, FL, GA, IA, IN, MN, NC, NJ, TN, WI. Australia, Brazil, Buenos Aires, Canada, Colombia, Hong Kong, Japan, Korea, Mexico, Netherlands, Thailand and the United Kingdom. There were no government accounts involved.
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.
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