FDA Medical Device Recalls (openFDA)
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, Potassium, ionized Calcium, pH, pCO2, pO2 and Hematocrit.
- Recall number
- Z-0952-2009
- Recalling firm
- Epocal
- 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.
- Status
- Terminated
- Initiated
- 2008-10-16
- Posted
- 2009-02-06
- Terminated
- 2009-02-06
- 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.
- Lot, serial or model codes
- Lot number 00260
- 510(k) numbers
- ["K061597"]
- PMA numbers
- not on file
- Product code
- CEM
- Firm FEI
- 3004959793
- Firm city
- Ottawa
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28