Recall Z-1465-06 · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Siemens Healthcare Diagnostics
RapidLab 1200 Systems, Model 1265 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division
| Date | Aug 29, 2006 (initiated Apr 4, 2006) |
| Status | Terminated |
| Reason | 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 | 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 | Domestic - 124 units, Foreign-364 units (all systems) |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031560 | BAYER RAPIDLAB 1200 SYSTEM Bayer Healthcare, LLC, Dec 17, 2003 |