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

FDA device recall Z-0457-2008 · posted 2008-01-04 · Terminated

Recall details

Recalling firm

bioMerieux, Inc.

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)

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

MDB

Quantity affected

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, Finl

Date initiated

2007-11-05

Date posted

2008-01-04

Date terminated

2009-12-08

Location

Durham, NC