Customer reported urobilinogen (uro) results by status+ method higher than by visual method for two (2) patient samples when using multistix 10sg lot 506076 (exp 2016-12).Specifically, it was reported that samples read as 2mg/dl visually were reported as 8mg/dl by status+ -- a 2 color block difference.One (1) partial bottle of multistix 10sg lot 506076 (total (b)(4) strips) were sent to (b)(4) technical operations for investigation.The submitted reagent strips showed no obvious visible damage or degradation.The bottle arrived tightly capped and containing the expected desiccant.Performance of supplied reagent was tested by both visual & status+ instrument methods using uro test solutions at 1mg/dl, 4mg/dl, & 8mg/dl concentration.Comparison of results from both methods showed 100% agreement at the 1mg/dl & 8mg/dl test levels.A the 4mg/dl level, 17% of visual results reported 1 color block lower and 67% of instrument results reported 1 color block higher.The customer observation of a 2 block color difference for samples tested both visually and by a status+ instrument with multistix 10sg lot 506076, as reported in gsms (b)(4), was observed; however, test results were found to meet expectation.All results were found to be within one color block of the assigned test solution value.The multistix 10sg product insert states that "results will usually be within one level of the true concentration.".
|