Recall Z-1362-2018 ยท KQO Automated Urinalysis System
Beckman Coulter Inc.
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
| Date | Mar 2, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Use error |
| Action | 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. |
| Quantity | 5247 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022774 | IQ 200 SYSTEM Intl. Remote Imaging Systems, Oct 21, 2002 |