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Class 2 Device Recall BacT/VIEW C.30a Software update (P/N 5145151) |
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Date Initiated by Firm |
December 19, 2006 |
Date Posted |
March 22, 2007 |
Recall Status1 |
Terminated 3 on December 08, 2009 |
Recall Number |
Z-0644-2007 |
Recall Event ID |
37141 |
510(K)Number |
K903505 K934593 K954468 K981736
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Product Classification |
diagnostic data management system - Product Code MDB
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Product |
BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, bioMerieux, Inc., P. O. Box 15969, Durham, NC 27704-0969 USA |
Code Information |
All BacT/ALERT 3D instruments (version C.30a only, not the C.30 version of software). |
Recalling Firm/ Manufacturer |
bioMerieux, Inc. 100 Rodolphe St Durham NC 27712-9402
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For Additional Information Contact |
Brian Brundidge 919-620-2968
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Manufacturer Reason for Recall |
Bottle data is not sent to BacT/ALERT 3D instrument.
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FDA Determined Cause 2 |
Other |
Action |
A customer notification advising customers of the issues and the precautions were sent on/about December 20, 2006. |
Quantity in Commerce |
1233 disks |
Distribution |
Worldwide, including USA, Canada, UK, Italy, France, Spain, Germany, Poland, Chile, Japan and the Netherlands. |
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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