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U.S. Department of Health and Human Services

Class 2 Device Recall BacT/VIEW C.30a Software update (P/N 5145151)

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  Class 2 Device Recall BacT/VIEW C.30a Software update (P/N 5145151) see related information
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  
Product Classification diagnostic data management system - Product Code MDB
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/
bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact Brian Brundidge
Manufacturer Reason
for Recall
Bottle data is not sent to BacT/ALERT 3D instrument.
FDA Determined
Cause 2
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

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 = MDB and Original Applicant = ORGANON TEKNIKA CORP.