Recall Z-1095-2007 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radiometer America Inc
ABL 800 FLEX series blood gas analyzers containing software version 5.24.
| Date | Jul 24, 2007 (initiated Nov 13, 2006) |
| Status | Terminated |
| Reason | Software anomaly. Protein removing program incorporated in the operating software for Versions: V3.833 and V5.24, of the ABL700 and ABL800 Blood Gas Analyzers, may allow for protein build up on the electrode membranes of blood gas analyzers. This condition can influence analyzer results. When the protein removal program is run too frequently, more than once a week, or when running the protein rem |
| Root cause | Software design |
| Action | The firm issued a 'Safety Alert Notice' [FAN 915-248] to all customers which received the recalled ABL700 and ABL800 Analyzers equipped with the referenced software. The 11/13/2006 notice describes the problem concerning the Protein Removal program to the user/customers and emphasizes that the frequency of running the program in these software versions must be no more than once a week in order to prevent the protein build-up problem. It also contains additional recommendations for the user/customers for operation of these analyzer and informs the customers that a Radiometer Service Rep. will |
| Quantity | 464 |
| Distribution | The recalled analyzers were distributed to customers nationwide throughout the U.S. and in some parts of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041874 | ABL800 FLEX Radiometer Medical Aps, Oct 8, 2004 |