FDA Medical Device Recalls (openFDA)
bioMerieux, Inc.: 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
- Recall number
- Z-0644-2007
- 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
- Status
- Terminated
- Initiated
- 2006-12-19
- Posted
- 2007-03-22
- Terminated
- 2009-12-08
- Reason
- Bottle data is not sent to BacT/ALERT 3D instrument.
- Root cause
- Other
- Action
- A customer notification advising customers of the issues and the precautions were sent on/about December 20, 2006.
- Quantity
- 1233 disks
- Distribution
- Worldwide, including USA, Canada, UK, Italy, France, Spain, Germany, Poland, Chile, Japan and the Netherlands.
- Lot, serial or model codes
- All BacT/ALERT 3D instruments (version C.30a only, not the C.30 version of software).
- 510(k) numbers
- ["K903505","K934593","K954468","K981736"]
- 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