Beckman Coulter—Iris iQ200 Series Urine Microscopy Analyzers: May Underreport Casts

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In a February 22, 2018, Urgent Medical Device Recall letter submitted by an ECRI Institute member hospital, Beckman Coulter states that if per high-power field (/HPF) units of measurement for casts are selected in the software of the above systems, but the abnormal threshold and/or grading format is set up based on reporting "per low-power field (/LPF)" or 'per microliter (/μL), the above systems may underreport casts. This problem may occur during initial method validation or if settings are altered after the initial validation. Beckman Coulter also states that the worst case scenario is the potential for erroneous false-low results or failure to flag abnormal results for white blood cell casts or red blood cell casts. Beckman Coulter further states that if the results indicate that casts are completely absent or not detected, these results are still valid. If casts are present, they will still be detected. Beckman Coulter states that if the casts are present, incorrect settings can lead to the following outcomes for all cast categories (unclassified casts,...