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Class 3 Device Recall |
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Date Initiated by Firm |
September 17, 2004 |
Date Posted |
February 01, 2005 |
Recall Status1 |
Terminated 3 on December 08, 2009 |
Recall Number |
Z-0456-05 |
Recall Event ID |
30261 |
510(K)Number |
K903505
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Product Classification |
System, Blood Culturing - Product Code MDB
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Product |
BacT/ALERT¿(BTA) Classic instruments. |
Code Information |
All codes associated with the product. |
Recalling Firm/ Manufacturer |
bioMerieux 100 Rodolphe St Bldg 1300 Durham NC 27712-9402
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For Additional Information Contact |
Jocelyn Jennings 919-620-2968
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Manufacturer Reason for Recall |
Over heating of memory board.
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FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by letter on September 17, 2004. |
Quantity in Commerce |
1626 units |
Distribution |
Nationwide, Argentina, Australia, Belgium, Brazil, Canada, Colombia, Denmark, Finland, France, Germany, Greece, India, Indonesia, Italy, Japan, Korea, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Thailand, Turkey, UK. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = MDB and Original Applicant = ORGANON TEKNIKA CORP.
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