It has come to our attention that The U.S. Food and Drug Administration (FDA) has issued an Class I Recall to remind healthcare providers and patients that GEM Premier 4000 PAK Cartridges for use on the GEM Premier 4000 portable critical care system, which is manufactured by Instrumentation Laboratory Company, may give inaccurate results.
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.
To avoid this, the manufacturer recommended customers to follow the instructions to disable the potassium test to eliminate the potential of erroneous result reporting.
According to the local supplier, Hong Kong is affected. The local supplier has contacted the affected customers for corrective actions
For details, please refer to the following link:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm266113.htm
If you are in possession of the affected product, please contact your supplier for necessary actions.