Bayer Rapidpoint 405 Blood Gas Analyzer
FDA device recall Z-0066-04 · posted 2003-10-24 · Terminated
Recall details
- Recalling firm
- Bayer Corp.
- Reason for recall
- Potential for bias shift in pO2 values due to air bubble in sample path
- Action taken
- Bayer notified each customer by telephone and followed with a FedEx letter dated 9/26/03 providing upgraded software version 3.1 to install .
- Root cause
- Other
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 494 units
- Distribution
- Nationwide Foreign: Australia, Austria, Belgium. Canada, France, Germany, Italy, Japan, Korea, Mexico, Netherlands, Russia, S Ireland, Spain, Switzerland
- Date initiated
- 2003-09-26
- Date posted
- 2003-10-24
- Date terminated
- 2004-02-04
- Location
- Medfield, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BAYER RAPIDPOINT 405 SYSTEM (K020616) | Bayer Diagnostics Corp. | 2002-07-17 |