Recall Z-0066-04 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Bayer Corp.
Bayer Rapidpoint 405 Blood Gas Analyzer
| Date | Oct 24, 2003 (initiated Sep 26, 2003) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020616 | BAYER RAPIDPOINT 405 SYSTEM Bayer Diagnostics Corp., Jul 17, 2002 |