Recall Z-0952-2009 ยท CEM Electrode, Ion Specific, Potassium
Epocal
EPOC BGE Test Card The EPOC Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of whole blood samples in the laboratory or at the point of care in hospitals, nursing homes, or other clinical care institutions. The Blood Gas Electrolyte (BGE) test card panel of this device includes sensors for testing Sodium, Po
| Date | Feb 6, 2009 (initiated Oct 16, 2008) |
| Status | Terminated |
| Reason | elevated range of potassium levels |
| Root cause | Other |
| Action | The recalling firm visited the hospital on 10/18/08 to conduct an investigation. At the end of the visit, the firm representatives removed the remaining cards from the hospital and returned to the manufacturing location. |
| Quantity | 1000 test cards |
| Distribution | Nationwide Distribution --- including state of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061597 | EPOC BLOOD ANALYSIS SYSTEM Epocal, Inc., Sep 27, 2006 |