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.
FDA Recall Z-0952-2009 · Posted 2009-02-06
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Recalling FirmEpocal
Recall StatusTerminated
Product CodeCEM
Date Initiated2008-10-16
Date Terminated2009-02-06
Product Quantity1000 test cards
Reason for Recall
elevated range of potassium levels
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide Distribution --- including state of CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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