Z-0643-2007

BacT/ALERT FA Culture Bottles, 30 ml, for in vitro diagnostic use, BioMerieux, Inc., Durham, NC 27704

Name: Z-0643-2007 BacT/ALERT FA Culture Bottles, 30 ml, for in vitro diagnostic use, BioMerieux, Inc., Durham, NC 27704
Creator: bioMerieux, Inc.
Published: 2007-01-11
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2007-01-11 / Terminated

FDA source

bioMerieux, Inc. began a recall of BacT/ALERT FA Culture Bottles, 30 ml, for in vitro diagnostic use, BioMerieux, Inc., Durham, NC 27704 on 2007-01-11. The reason FDA records is "Bacillus sp. contamination was detected in inoculated and uninoculated bottles of BacT/ALERT FA Culture bottles". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0643-2007
Status: Terminated
Initiated: 2007-01-11
Posted: 2007-03-22
Terminated: 2009-12-08
Recalling firm: bioMerieux, Inc.
Product: BacT/ALERT FA Culture Bottles, 30 ml, for in vitro diagnostic use, BioMerieux, Inc., Durham, NC 27704
Product code: MDB System, Blood Culturing
Reason for recall: Bacillus sp. contamination was detected in inoculated and uninoculated bottles of BacT/ALERT FA Culture bottles.
FDA root cause: Other
Action: Consignees were notified by letter on/about 01/12/2007.
Quantity in commerce: 2136 cases (100 bottles per case)
Distribution: Worldwide, including USA, Austria, Denmark, Finland, France, Greece, Guyana, Italy, Libya, Netherlands, Norway, New Caledonia, Poland, Portugal, Singapore, Slovenia, Spain, Tanzania, and Sweden.
Product codes and lots: Lot 1014768

Product code MDB

K020813Class IBact/alert Fa Culture BottlebioMerieux, Inc. / cleared 2002-04-17

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)