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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 November 05, 2007
Date Posted January 04, 2008
Recall Status1 Terminated 3 on December 08, 2009
Recall Number Z-0457-2008
Recall Event ID 45799
Product Classification Blood Culturing System - Product Code MDB
Product bioMerieux, BacT/ALERT¿ FA Culture Bottles, bioMerieux, Inc., Durham, NC 27704
Code Information Lot Numbers: 1017685, 101793 and 1017788
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact James M. Clinton
919-620-2599
Manufacturer Reason
for Recall		 Duplicate Bottle Indentification -- Three lot numbers of BacT/ALERT¿ FA Culture Bottles labels contained duplicate bottle identification (Bottle ID) barcode numbers. (Lots 1017685 and 1017788 contain the same series of Bottle ID's; Lot 1017693 contains duplicate Bottle ID's within the lot and may share Bottle ID's with both lots 1017685 and 1017788)
FDA Determined
Cause 2		 Process control
Action bioMerieux notified all Consignees with a Urgent Product Recall Notice letter on 11/05/2007. They were instructed to examine their inventory to determine if they have any remaining inventory of the 3 affected lots. If they have any of these bottles they were instructed to stop using them and destroy all remaining inventory. A Customer Acknowledgement Form was attached to be completed and returned to bioMerieux via fax or mail. There were also instructions attached for the use of Generic Bottle Barcodes and Creating a Unique Bottle ID.
Quantity in Commerce 7,025
Distribution Worldwide Distribution-USA including countries of Australia, Austria, Bangladesh, Brazil, Bulgaria, Byelorussia, Chile, China, Colombia, Croatia, Denmark, Dijbouti, Estonia, Federation of Russia, Finland, France, Germany, Greece, Guadeloupe, India, Israel, Italy, Korea, Kuwait, Martinique, Mexico, Netherlands, New Caledonia, Norway, Panama, Poland, Portugal, Reunion, Saudi Arabia, Serbia Montenegro, Slovenia, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vietnam.
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.
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