Recall Z-0682-2019 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radiometer America Inc
ABL800 analyzer, model numbers 393-800 and 393-801.
| Date | Jul 3, 2018 |
| Status | Terminated |
| Reason | The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur. |
| Root cause | Software design |
| Action | The recalling firm issued letters dated 7/3/2018 on 7/3/2018 via FedEx. |
| Quantity | 2,131 analyzers |
| Distribution | Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041874 | ABL800 FLEX Radiometer Medical Aps, Oct 8, 2004 |