A device used to measure potassium levels in the blood is being recalled because it is registering too low. This malfunction can result in inappropriate patient treatment and may cause serious adverse health consequences, including death.

The Class 1 recall involves the GEM Premier 4000 PAK Cartridges for use on the GEM Premier 4000 System. These products were manufactured and distributed from May 2006 through July 2011. A Class 1 recall is the most serious recall the Food and Drug Administration (FDA) can issue and involves situations in which there is a reasonable probability that use of the product will cause serious health consequences or death.

The GEM Premier 4000 PAK cartridges are used on the GEM Premier 4000 portable critical care system by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The recall was initiated because potassium test results on the GEM Premier 4000 are too low when compared to a reference analyzer with biases exceeding the allowable error claim of plus or minus 0.5 mmol/L by as much as 2.0 mmo/L.

Potassium is a nutrient that is critical to the function of nerve and muscles cells, including those in your heart. Low potassium levels, known as hypokalemia, can cause weakness, fatigue, muscle cramps, constipation and abnormal heart rhythms. High potassium levels, known as hyperkalemia, can cause irregular heartbeat, nausea, weakness and cardiac arrest.

Customers were directed to follow instructions to disable the potassium test to eliminate the potential for erroneous results. Any health problems caused by this device should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/report/htm.

Source: FDA