A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System: Class I Recall – Innaccurate Results. According to the Food & Drug Administration FDA’s MedWatch:
Potassium test results too low when compared to a reference analyzer, which may lead to inappropriate patient treatment and may cause serious adverse health consequences, including death.
For more information on the drug or medical device recall or safety alert, read the Food & Drug Administration’s FDA’s drug or medical device recall or safety alert: GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System: Class I Recall – Innaccurate Results.
To report an adverse reaction, problem or other issue with a drug or medical device, submit a drug or medical device complaint to the government at fda.gov or MedWatch.
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