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U.S. Department of Health and Human Services

Class 2 Device Recall BacT/ALERT FA Culture Bottles.

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  Class 2 Device Recall BacT/ALERT FA Culture Bottles. see related information
Date Initiated by Firm January 11, 2007
Date Posted March 22, 2007
Recall Status1 Terminated 3 on December 08, 2009
Recall Number Z-0643-2007
Recall Event ID 37133
510(K)Number K020813  
Product Classification Culture Bottles - Product Code MDB
Product BacT/ALERT¿ FA Culture Bottles, 30 ml, for in vitro diagnostic use, BioMerieux, Inc., Durham, NC 27704
Code Information Lot 1014768
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact John Cusack, Sr.
919-620-2803
Manufacturer Reason
for Recall		 Bacillus sp. contamination was detected in inoculated and uninoculated bottles of BacT/ALERT FA Culture bottles.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on/about 01/12/2007.
Quantity in Commerce 2136 cases (100 bottles per case)
Distribution Worldwide, including USA, Austria, Denmark, Finland, France, Greece, Guyana, Italy, Libya, Netherlands, Norway, New Caledonia, Poland, Portugal, Singapore, Slovenia, Spain, Tanzania, and Sweden.
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 = BIOMERIEUX, INC.
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