Z-0066-04

Bayer Rapidpoint 405 Blood Gas Analyzer

Name: Z-0066-04 Bayer Rapidpoint 405 Blood Gas Analyzer
Creator: Bayer Corp.
Published: 2003-09-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-09-26 / Terminated

FDA source

Bayer Corp. began a recall of Bayer Rapidpoint 405 Blood Gas Analyzer on 2003-09-26. The reason FDA records is "Potential for bias shift in pO2 values due to air bubble in sample path". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0066-04
Status: Terminated
Initiated: 2003-09-26
Posted: 2003-10-24
Terminated: 2004-02-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Bayer Rapidpoint 405 Blood Gas Analyzer
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Potential for bias shift in pO2 values due to air bubble in sample path
FDA 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 in commerce: 494 units
Distribution: Nationwide Foreign: Australia, Austria, Belgium. Canada, France, Germany, Italy, Japan, Korea, Mexico, Netherlands, Russia, S Ireland, Spain, Switzerland
Product codes and lots: Software Versions below 3.1

Product code CHL

K020616Class IIBayer Rapidpoint 405 SystemBayer Diagnostics Corp. / cleared 2002-07-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)