FDA Medical Device Recalls (openFDA)
bioMerieux, Inc.: BacT/ALERT 3D Combo Systems Software, Blood Culturing System
- Recall number
- Z-0775-2007
- Recalling firm
- bioMerieux, Inc.
- Product
- BacT/ALERT 3D Combo Systems Software, Blood Culturing System
- Status
- Terminated
- Initiated
- 2006-08-14
- Posted
- 2007-05-03
- Terminated
- 2009-12-08
- Reason
- Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems.
- Root cause
- Other
- Action
- Consignees were notified via A Field Corrective Action Notification on/about 10/18/2006. A second notification was sent on October 31, 2006.
- Quantity
- 10790 units, total for all models
- Distribution
- Worldwide, including USA, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dutch Antilles, Egypt, Ecuador, Estonia, Faeroe Islands, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Korea, Latvia, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania , Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
- Lot, serial or model codes
- All Models
- 510(k) numbers
- ["K954468"]
- 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