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Epocal Inc

Last updated May 24, 2026

Information

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Device	Model / Reference	Registries	Class	Status
Capillary Tube, Care-Fill, Bundle Of 50	AT-0006-00-00	FDA UDI	Class I	Active
Epoc Host, Rx, Vet, Na, Refurb	HH-0R08-00-00	FDA UDI	N/A	Unknown
Epoc Reader, Veterinary, Heska	HR-1003-US-00	FDA UDI	N/A	Unknown
Blood Collection Tube Samples For Use With Point Of Care Blood Analyzer	K092849	FDA 510(k)	Class II	Active
epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test	K171247	FDA 510(k)	Class II	Active
Epoc Blood Analysis System	K061597	FDA 510(k)	Class II	Active
Blood Gas, Electrolyte And Metabolite Test Card	K090109	FDA 510(k)	Class II	Active
Epoc Chloride Test And Epoc Creatinine Test	K113726	FDA 510(k)	Class II	Active
Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary Tube	K093297	FDA 510(k)	Class I	Active
epoc Blood Analysis System	K200107	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 13, 2013	Z-1971-2013	—	terminated	This recall is being initiated because the affected lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end of the Glucose test sensor (>400 mg/dl). Specifically, after a period of storage of three (3) to four (4) months, the Glucose sensor may report low results at the high end of the measurement range.
Jun 28, 2011	Z-2034-2012	—	terminated	Customer reported problem while performing incoming QC of newly received lot of test cards. Liquid quality control results were found to be out of range. Further investigation by Epocal determined that a portion of the test card lot (approximately 3000 cards) could potentially report low glucose results.
Oct 16, 2008	Z-0952-2009	—	terminated	elevated range of potassium levels

Establishments registered with the FDA under this company group, matched by name.