Recall Z-0157-2020 ยท JGS Electrode, Ion Specific, Sodium
Vital Scientific N.V.
Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
| Date | Jan 10, 2012 |
| Status | Terminated |
| Reason | The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced. |
| Root cause | Component design/selection |
| Action | The firm reached out to consignees via phone to inform them of the affected product. |
| Quantity | 5 instruments |
| Distribution | US Nationwide in the states of NY, and UT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102647 | ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE... Elitechgroup Vital Scientific BV, Mar 24, 2011 |