FDA Medical Device Recalls (openFDA)
bioMerieux, Inc.: bioMerieux, BacT/ALERT FA Culture Bottles, bioMerieux, Inc., Durham, NC 27704
- Recall number
- Z-0457-2008
- Recalling firm
- bioMerieux, Inc.
- Product
- bioMerieux, BacT/ALERT FA Culture Bottles, bioMerieux, Inc., Durham, NC 27704
- Status
- Terminated
- Initiated
- 2007-11-05
- Posted
- 2008-01-04
- Terminated
- 2009-12-08
- Reason
- 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)
- Root cause
- 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
- 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.
- Lot, serial or model codes
- Lot Numbers: 1017685, 101793 and 1017788
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MDB
- Firm FEI
- 3002769706
- Firm city
- Durham
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28