FDA Medical Device Recalls (openFDA)
bioMerieux: BacT/ALERT(BTA) Classic instruments.
- Recall number
- Z-0456-05
- Recalling firm
- bioMerieux
- Product
- BacT/ALERT(BTA) Classic instruments.
- Status
- Terminated
- Initiated
- 2004-09-17
- Posted
- 2005-02-01
- Terminated
- 2009-12-08
- Reason
- Over heating of memory board.
- Root cause
- Other
- Action
- Consignees were notified by letter on September 17, 2004.
- Quantity
- 1626 units
- Distribution
- Nationwide, Argentina, Australia, Belgium, Brazil, Canada, Colombia, Denmark, Finland, France, Germany, Greece, India, Indonesia, Italy, Japan, Korea, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Thailand, Turkey, UK.
- Lot, serial or model codes
- All codes associated with the product.
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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