Recall Z-1201-2007 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Sendx Medical Inc
ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863
| Date | Aug 29, 2007 (initiated Jun 4, 2007) |
| Status | Terminated |
| Reason | The ABL8O FLEX software version 1.10 contains errors in the derived parameter calculation for cBase(B,ox) and cBase(Ecf,ox). These incorrect calculations result in a mild to moderate lowering of the base excess value, the severity depending on the concentration of hemoglobin and the oxygen saturation in the sample. Elevated hemoglobin concentrations have the greatest impact on this calculation err |
| Root cause | Other |
| Action | A total of eight (8) distributors and the Radiometer main office in Denmark were sent the recall package (Field Action Notice) by email on 6-6-07. The distributors were provided background information and specific instruction on the steps to perform to correct the problem. The Recall package included a Management Cover for Field Action Notes and the Field Action Notice. Radiometer has released a subsequent software upgrade (v.1.11) to correct the two problems noted in the Recall Notice. |
| Quantity | 165 software upgrade CDs |
| Distribution | In US to Cleveland, OH and Worldwide to Belgium, Denmark, France, Germany, The Netherlands, Sweden & United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051804 | ABL80 FLEX ANALYZER Sendx Medical, Inc., Nov 1, 2005 |