Device product
BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370
Z-1362-2018
Product summary
- Event
- Event 79566
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5247 units
- Official record key
device-enforcement:Z-1362-2018
Official wording
Reason: Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high-power field (/HPF) units of measurement for casts are selected in the iQ200 software, but the abnormal threshold and/or grading format is set up based on reporting per low-power field (/LPF)* or *per microliter. This may occur during initial method validation or if settings are altered after the initial validation.
Code information: All
Distribution pattern: Worldwide
Derived failure modes
-
Unknown
Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high-power field (/HPF) units of measurement for casts are selected in the iQ200 software, but the abnormal threshold and/or grading format is set up based on reporting per low-power field (/LPF)* or *per microliter. This may occur during initial method validation or if settings are altered after the initial validation.