The Recall Desk
HighFDA (Devices)·Z-1971-2013·Announced 2013-08-21

Epocal BGEM Test Card Recall for Potential Glucose Measurement Errors

Epocal is recalling 828,750 BGEM Test Cards because the glucose sensor may report low results at high concentrations after 3-4 months of storage.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device that may provide inaccurate diagnostic results (low glucose readings at high concentrations), which poses a risk of harm if relied upon for clinical decisions, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Epocal is recalling 828,750 units of the epoc BGEM Test Card (Catalogue number CT-1004-00-00). This medical device is used for quantitative testing of samples for pH, pCO2, pO2, Sodium, Potassium, Ionized Calcium, Glucose, Lactate, and Hematocrit. The recall covers specific lots with expiration dates ranging from March 26, 2013, to July 04, 2013.

The recall was initiated because the affected lots may yield results that are not consistent with stated precision performance criteria at high-end glucose concentration values (greater than 400 mg/dl). Specifically, after a period of storage of three to four months, the Glucose sensor may report low results at the high end of the measurement range.

The product was distributed worldwide, including the United States (nationwide, including the District of Columbia, US Virgin Islands, and Puerto Rico) and numerous international countries such as Canada, Germany, Japan, and India. Users should check their inventory for the specific lot numbers and expiration dates listed in the official recall notice and discontinue use of affected units.

The recalled product

Product
epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.
Manufacturer
Epocal
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
828,750

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Related recalls

Same hazard · inaccurate diagnostic result

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