Recall Z-0952-2009
Epocal · initiated October 16, 2008
Product
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, Potassium, ionized Calcium, pH, pCO2, pO2 and Hematocrit.
Codes / lots: Lot number 00260
Reason for recall
elevated range of potassium levels
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0952-2009
- Initiated
- October 16, 2008
- Posted by FDA
- February 6, 2009
- Terminated
- February 6, 2009
- Product code
- CEM – Electrode, Ion Specific, Potassium
- Quantity
- 1000 test cards
- Distribution
- Nationwide Distribution --- including state of CA.
- Recalling firm
- Epocal, Ottawa