Recall Z-1386-06 ยท JFP Electrode, Ion Specific, Calcium
Radiometer America Inc
Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series, manufactured from 8/1998 through 11/2004.
| 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 | 1615 devices |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002290 | ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) Radiometer Medical A/S, Sep 13, 2000 |
| K980130 | ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM Radiometer America, Inc., Feb 9, 1998 |
| K991417 | ABL 735 ANALYZER Radiometer America, Inc., Nov 24, 1999 |
| K992859 | ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE Radiometer America, Inc., Jan 10, 2000 |