Company:Beckman Coulter Inc.
Date of Enforcement Report 4/18/2018
Class lI:

PRODUCT

BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer
Recall Number Z-1362-2018

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.

RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea CA on 3/2/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
5247 units

DISTRIBUTION
Nationwide and Internationally

___________________________________