Device Recall BECKMAN COULTER1Q200 Series Urine Microscopy Analyzer 의 리콜

Recall

79566

Class 2

Z-1362-2018

2018-03-02

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162661

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.

The customers were contacted initially by the Urgent Medical Device Recall letter on 03/028/2018 delivered by email and US Mail. Beckman Coulter will schedule a sites visit to verify the reporting units of measurement for casts for the laboratory within 90 days of this recall initiation. The use of Casts/HPF is not a common setting worldwide.