Home » FDA Issues Medical Device Recall for GEM Premier 4000 PAK Cartridges
FDA Issues Medical Device Recall for GEM Premier 4000 PAK Cartridges
The FDA is issuing a Class I recall for Instrumentation Laboratory’s GEM Premier 4000 PAK Cartridges for use on the GEM Premier 4000 System. 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 millimoles (mmol)/L by as much as 2.0 mmol/L.
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