Z-0952-2009

EPOC BGE Test Card The EPOC Blood Analysis System is intended for use by trained medical professionals as an...

Name: Z-0952-2009 EPOC BGE Test Card The EPOC Blood Analysis System is intended for use by trained medical professionals as an...
Creator: Epocal
Published: 2008-10-16
License: https://open.fda.gov/license/

Epocal Inc / initiated 2008-10-16 / Terminated

FDA source

Epocal began a recall of 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... on 2008-10-16. The reason FDA records is "elevated range of potassium levels". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0952-2009
Status: Terminated
Initiated: 2008-10-16
Posted: 2009-02-06
Terminated: 2009-02-06
Recalling firm: Epocal Inc
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.
Product code: CEM Electrode, Ion Specific, Potassium
Reason for recall: elevated range of potassium levels
FDA 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 in commerce: 1000 test cards
Distribution: Nationwide Distribution --- including state of CA.
Product codes and lots: Lot number 00260

Product code CEM

K061597Class IIEpoc Blood Analysis SystemEpocal, Inc. / cleared 2006-09-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)