Beckman Coulter Inc. recalls iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320…

Recall date

October 28, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0914-2020

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

Worldwide distributions.

Why it was recalled

Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis.