EPOC BGE Test Card recallZ-0952-2009 · Epocal · initiated Oct 16, 2008
Terminated All recalls posted in February 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Epocal or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
elevated range of potassium levels
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0952-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 16, 2008
- Posted by the FDA
- Feb 6, 2009
- Recalling firm
- Epocal
- Quantity
- 1000 test cards
- Product code
- CEM
- FDA submissions
- K061597
- Distribution
- Nationwide Distribution --- including state of CA.
Product description
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.
Code information (models, lots, serial numbers)
Lot number 00260
Other devices under the same FDA submission
1 device cleared under K061597 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- epoc Host2 11413524Epocal Inc · ELECTRODE, ION SPECIFIC, CALCIUM1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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