Beckman Coulter Inc.: Medical Device Recall in 2018 - (Recall #: Z-1362-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 2, 2018

Date Posted: April 18, 2018

Recall Number: Z-1362-2018

Event ID: 79566

Reason for Recall:

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.

Status: Terminated

Product Quantity: 5247 units

Code Information:

All

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated