Recall Z-0683-06 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Bayer Healthcare, LLC (Diagnostics Division)
Brand Name: RapidLab 1200 System, Model 1245, Part Number 05061537; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test system.
| Date | Mar 29, 2006 (initiated Jan 20, 2006) |
| Status | Terminated |
| Reason | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031560 | BAYER RAPIDLAB 1200 SYSTEM Bayer Healthcare, LLC, Dec 17, 2003 |