FDA Medical Device Recalls (openFDA)
Bayer Corp.: Bayer Rapidpoint 405 Blood Gas Analyzer
- Recall number
- Z-0066-04
- Recalling firm
- Bayer Corp.
- Product
- Bayer Rapidpoint 405 Blood Gas Analyzer
- Status
- Terminated
- Initiated
- 2003-09-26
- Posted
- 2003-10-24
- Terminated
- 2004-02-04
- Reason
- Potential for bias shift in pO2 values due to air bubble in sample path
- Root cause
- Other
- Action
- Bayer notified each customer by telephone and followed with a FedEx letter dated 9/26/03 providing upgraded software version 3.1 to install .
- Quantity
- 494 units
- Distribution
- Nationwide Foreign: Australia, Austria, Belgium. Canada, France, Germany, Italy, Japan, Korea, Mexico, Netherlands, Russia, S Ireland, Spain, Switzerland
- Lot, serial or model codes
- Software Versions below 3.1
- 510(k) numbers
- ["K020616"]
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 3002637618
- Firm city
- Medfield
- Firm state
- MA
- 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