Recall Z-1387-06 ยท JFP Electrode, Ion Specific, Calcium
Radiometer America Inc
Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzers, ABL-800 series, manufactured from 8/2004 through 9/2005.
| Date | Aug 10, 2006 (initiated Sep 29, 2005) |
| Status | Terminated |
| Reason | Under certain circumstances, the ABL 700 &800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers intermittently provide incorrect (too low) result values for Calcium (Ca) and Sodium (Na). |
| Root cause | Other |
| Action | The consignees were notified of this recall by a letter, dated 9/29/2005. The letter informs the customers of this potential problem and the availability of new updated software which will correct the problem. The letter goes on to inform the customer that a Radiometer Service Engineer wil be contacting them shortly in order to arrange for a convenient time to install the software update. Along with the letter, the customer is provided a copy of an additional page and a CD concerning the function and operation of the new software, which is to be added to the customer''s Operator''s Manual. |
| Quantity | 196 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 |