October 9, 2024Medical DevicesFDA
Healgen Scientific Llc recalls Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is emp
Hazard: The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products have shown reduced sensitivity, or potential false negative results for the detection of urinary protein by way of uneven color fading on the total protein test pad. This could lead to a delay in the identification of potential kidney diseases, their evaluation, and/or other conditions associated with elevated protein levels in urine and subsequently a delay in patient treatment.