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U.S. Department of Health and Human Services

Class 2 Device Recall Simplastin Excel

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  Class 2 Device Recall Simplastin Excel see related information
Date Initiated by Firm February 04, 2003
Date Posted March 06, 2003
Recall Status1 Terminated 3 on January 21, 2004
Recall Number Z-0629-03
Recall Event ID 25587
510(K)Number K864283  
Product Classification Test, Time, Prothrombin - Product Code GJS
Product Simplasitin Excel, 10 x 6ml, 25200, For Prothrombin Time determinations, bioMerieux, Inc. Durham, NC 27704. The product consists of two vials, a thromboplastin reagent and a diluent ( the vials are mixed together before use).
Code Information Lot numbers: 161402, 161431, 161432, 161477, 161448, 161479, 161507, 161508, 161550, 161551, 161583, 161585, 161595, 161657, 161658. Expanded 3/19/2003 to include lot #161639, 16160 and 1611711. Final expansion of recall initiated 5/30/2003 to include Product Number 252001 (20ml), lot numbers161403, 161480, 161509, 161510, 161552 161586 and 161596.
Recalling Firm/
Manufacturer		 Biomerieux, Inc.
100 Rodolphe Street
Durham NC 27712
For Additional Information Contact Anita McClernon
919-620-2288
Manufacturer Reason
for Recall		 Product is being recalled due to vial to vial variability of clotting time results.
FDA Determined
Cause 2		 Other
Action Consignees were notified by a Customer Notification letter sent via regular mail on/about February 4, 2003 with response form attached. An additional cover letter was sent to international affiliates/distributors who were responsible for notifying their customers. Consignees were asked to report the amount of product on hand and to destroy the product. On March 18th the firm expanded the recall. Consignees were notified by letter on March 19th , and March 31, 2003 and 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 62,435 units, Expanded Lot #161659, 3525 boxes; 161660, 1489 boxes; 161711, 3990 boxes
Distribution Product was distributed nationwide and Brazil, Canada, China, Japan, Korea, Mexico, The Netherlands, Taiwan, Venezuela
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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