Z-1465-06

RapidLab 1200 Systems, Model 1265 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC...

Name: Z-1465-06 RapidLab 1200 Systems, Model 1265 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC...
Creator: Siemens Healthcare Diagnostics
Published: 2006-04-04
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2006-04-04 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics began a recall of RapidLab 1200 Systems, Model 1265 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division on 2006-04-04. The reason FDA records is "Invalid CO-oximeter values; Bayer HealthCare determined that under very specific conditions, the RapidLab 1245 or RapidLab 1265 systems may report invalid CO-oximeter values to an LIS, Rapidlink, or Rapidcomm™ data...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1465-06
Status: Terminated
Initiated: 2006-04-04
Posted: 2006-08-29
Terminated: 2012-07-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: RapidLab 1200 Systems, Model 1265 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Invalid CO-oximeter values; Bayer HealthCare determined that under very specific conditions, the RapidLab 1245 or RapidLab 1265 systems may report invalid CO-oximeter values to an LIS, Rapidlink, or Rapidcomm™ data management system.
Root cause tag: software
FDA root cause: Software design
Action: On 4/04/06, Bayer HealthCare LLC (Diagnostics Division) sent Support Bulletins to all affected Bayer HealthCare LLC Branches via e-mail in order to inform them of the issue, and to provide them with instructions for the interim work-around until the new software version is installed. Customer Bulletins were prepared and sent to the Branches both in the United States and globally for communication with the affected customers.
Quantity in commerce: Domestic - 124 units, Foreign-364 units (all systems)
Distribution: Worldwide
Product codes and lots: Part No. 05063769; all units using Version 1.0, 1.01, or 1.02 software connected to LIS, Rapidlink¿, or Rapidcomm™ data management systems.

Product code CHL

K031560Class IIBayer Rapidlab 1200 SystemBayer Healthcare, LLC / cleared 2003-12-17

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 2026-09-06. View this recall on fda.gov (opens on fda.gov)