—#162661

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

FDA product code: KQO — Automated Urinalysis System
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K022774
Affected lot / code info: All

Why it was recalled

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 (FDA determination)

Use error

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Worldwide

Timeline

Recall initiated: 2018-03-02
Terminated: 2023-07-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162661. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.