Recall Z-1318-06 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radiometer America Inc
Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-800 series.
| Date | Aug 2, 2006 (initiated Jun 17, 2005) |
| Status | Terminated |
| Reason | Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase. |
| Root cause | Other |
| Action | The customers were apprised of this situation with a recall letter issued by the firm on 6/17/2005. In addition, new Operators Manuals were sent to the customers. In the letter, the customers were advised that a Service Engineer would be contacting them shortly in order to arrange for the installation of the software upgrade. The firm''s Service Engineers visited each customer location and installed software upgrades. Version 3.831 software was installed on the 700 Series Analyzers and Version 4.14 was installed on the 800 Series Analyzers. According to the firm, these software corrections |
| Quantity | 108 devices |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041874 | ABL800 FLEX Radiometer Medical Aps, Oct 8, 2004 |