| Class 3 Device Recall MDA Simplastin L | |
Date Initiated by Firm | July 31, 2003 |
Date Posted | October 15, 2003 |
Recall Status1 |
Terminated 3 on May 18, 2004 |
Recall Number | Z-1239-03 |
Recall Event ID |
27008 |
Product Classification |
Test, Time, Prothrombin - Product Code GJS
|
Product | MDA Simplastin L, Product number 252555, 10 vials, 40 ml ea (400 test each), bioMerieux Inc., Box 15969 Durham, North Carolina 27704-0969. |
Code Information |
Product #252555, Lot #500065, 500066 and 500067 |
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 2 | 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 | 857 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.
|
|
|
|