RapidLab 1200 Systems, Model 1245 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division
This recall has been terminated (originally issued August 29, 2006).
- Company
- Siemens Healthcare Diagnostics
- Recall Initiated
- April 4, 2006
- Posted
- August 29, 2006
- Terminated
- July 30, 2012
- Recall Number
- Z-1464-06
- Quantity
- Domestic - 124 units, Foreign-364 units (all systems)
- Firm Location
- Tarrytown, NY
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide
Lot / Code Info
Part No. 05061537; all units using Version 1.0, 1.01, or 1.02 software connected to LIS, Rapidlink¿, or Rapidcomm data management systems.
Root Cause
Software design
Action Taken
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.