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U.S. Department of Health and Human Services

Class 2 Device Recall BacT/ALERT FN Culture Bottles

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  Class 2 Device Recall BacT/ALERT FN Culture Bottles see related information
Date Initiated by Firm February 16, 2007
Date Posted August 22, 2007
Recall Status1 Terminated 3 on December 08, 2009
Recall Number Z-1189-2007
Recall Event ID 38433
510(K)Number K992432  
Product Classification Culture Bottles - Product Code MBD
Product BacT/ALERT¿ FN Culture Bottles, Product Number 259793
Code Information Product number 259743, Lot 1015145
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact Brian Brundidge
919-620-2599
Manufacturer Reason
for Recall		 Microbial Contamination: Bacillus sp. contamination was detected in inoculated bottles.
FDA Determined
Cause 2		 Other
Action Consignees were notified by Urgent Product Recall letter on 02/19/2007. They were instructed to destroy any unused inventory of this product lot that they have on hand.
Quantity in Commerce 2,403 cases (100 bottles per case)
Distribution Worldwide; USA, Austria, Bulgaria, Caledonia, China, Croatia, Curacao, Finland, France, Germany, Greece, Guadeloupe, Italy, Latvia, Mexico, Netherlands, Poland, Portugal, Spain, Saudi Arabia, Sultanate of Oman, Switzerland, Sweden, and United Kingdom
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 = MBD and Original Applicant = ORGANON TEKNIKA CORP.
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