FDA Medical Device Recalls (openFDA)
BIOMERIEUX, INC.: Bac T/ALERT 3D Control Module
- Recall number
- Z-0612-05
- Recalling firm
- BIOMERIEUX, INC.
- Product
- Bac T/ALERT 3D Control Module
- Status
- Terminated
- Initiated
- 2005-05-27
- Posted
- 2005-09-07
- Terminated
- 2006-09-21
- Reason
- A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle.
- Root cause
- Other
- Action
- Consignees were notified by letter on May 27, 2005.
- Quantity
- 744 units
- Distribution
- Nationwide, Argentina, Australia/N. Zealand, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Italy, Ivory Coast, Japan, Korea, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Sweden, Switzerland, Turkey, UK
- Lot, serial or model codes
- All Models
- 510(k) numbers
- ["K903505"]
- 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