GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System: Class I Recall - Inaccurate Results
MedSun: Newsletter #63, August 2011

FDA MedWatch Safety Alert

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 mmol/L. Use of this product may lead to inappropriate patient treatment and may cause serious adverse health consequences, including death. These products were manufactured and distributed from May, 2006 through July 2011. Customers were directed to follow the instructions to disable the potassium test to eliminate the potential of erroneous result reporting.

Additional Information:

FDA MedWatch Safety Alert. GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System: Class I Recall - Inaccurate Results. August 1, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm266113.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun