Z-0644-2007

BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, bioMerieux, Inc., P. O. Box...

Name: Z-0644-2007 BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, bioMerieux, Inc., P. O. Box...
Creator: bioMerieux, Inc.
Published: 2006-12-19
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2006-12-19 / Terminated

FDA source

bioMerieux, Inc. began a recall of BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, bioMerieux, Inc., P. O. Box 15969, Durham, NC 27704-0969 USA on 2006-12-19. The reason FDA records is "Bottle data is not sent to BacT/ALERT 3D instrument". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0644-2007
Status: Terminated
Initiated: 2006-12-19
Posted: 2007-03-22
Terminated: 2009-12-08
Recalling firm: bioMerieux, Inc.
Product: BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, bioMerieux, Inc., P. O. Box 15969, Durham, NC 27704-0969 USA
Product code: MDB System, Blood Culturing
Reason for recall: Bottle data is not sent to BacT/ALERT 3D instrument.
FDA root cause: Other
Action: A customer notification advising customers of the issues and the precautions were sent on/about December 20, 2006.
Quantity in commerce: 1233 disks
Distribution: Worldwide, including USA, Canada, UK, Italy, France, Spain, Germany, Poland, Chile, Japan and the Netherlands.
Product codes and lots: All BacT/ALERT 3D instruments (version C.30a only, not the C.30 version of software).

Product code MDB

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)