Z-0682-06

Brand Name: RapidLab 1200 System, Model 1240, Part Number 05060298; All RapidLab 1200 Systems with Software...

Name: Z-0682-06 Brand Name: RapidLab 1200 System, Model 1240, Part Number 05060298; All RapidLab 1200 Systems with Software...
Creator: Bayer Healthcare, LLC (Diagnostics Division)
Published: 2006-01-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2006-01-20 / Terminated / root cause: software

FDA source

Bayer Healthcare, LLC (Diagnostics Division) began a recall of Brand Name: RapidLab 1200 System, Model 1240, Part Number 05060298; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood... on 2006-01-20. The reason FDA records is "When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with...". 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-0682-06
Status: Terminated
Initiated: 2006-01-20
Posted: 2006-03-29
Terminated: 2012-05-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Brand Name: RapidLab 1200 System, Model 1240, Part Number 05060298; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test system.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions 1.0, 1.01, or 1.02. The correlation feature applies user-defined slope and offset parameters each time stored test results are recalled to the display.
Root cause tag: software
FDA root cause: Other
Action: Support Bulletins and Customer Bulletins were e-mailed to all Bayer HealthCare LLC Branches on 1/20/06 for distribution to the end user facilities (medical facilities).
Distribution: USA, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hong Kong, Italy, Japan, Korea, Malaysia, The Netherlands, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland.
Product codes and lots: All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02.

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 2026-09-05. View this recall on fda.gov (opens on fda.gov)