Bayer Healthcare, LLC (Diagnostics Division) 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Bayer Healthcare, LLC (Diagnostics Division)
Lot Codes / Batch Numbers
All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02.
Products Sold
All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02.
Bayer Healthcare, LLC (Diagnostics Division) is recalling Brand Name: RapidLab 1200 System, Model 1240, Part Number 05060298; All RapidLab 1200 Systems with S due to When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026