Z-0457-2008

bioMerieux, BacT/ALERT FA Culture Bottles, bioMerieux, Inc., Durham, NC 27704

Name: Z-0457-2008 bioMerieux, BacT/ALERT FA Culture Bottles, bioMerieux, Inc., Durham, NC 27704
Creator: bioMerieux, Inc.
Published: 2007-11-05
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2007-11-05 / Terminated / root cause: manufacturing process

FDA source

bioMerieux, Inc. began a recall of bioMerieux, BacT/ALERT FA Culture Bottles, bioMerieux, Inc., Durham, NC 27704 on 2007-11-05. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0457-2008
Status: Terminated
Initiated: 2007-11-05
Posted: 2008-01-04
Terminated: 2009-12-08
Recalling firm: bioMerieux, Inc.
Product: bioMerieux, BacT/ALERT FA Culture Bottles, bioMerieux, Inc., Durham, NC 27704
Product code: MDB System, Blood Culturing
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)
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: Lot Numbers: 1017685, 101793 and 1017788

Product code MDB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)