Beckman Coulter Inc. recalls iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 80…

Recall date

November 10, 2017

Source

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

Recall number

Z-1366-2018

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

United States: nationwide, including Puerto Rico; and Foreign: Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Bermuda, Bolivia, Brazil, Brunei Darussalam, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Guadeloupe, Guatemala, Hong Ko…

Why it was recalled

iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels causing erroneous results that could delay treatment for health conditions such as hematuria.

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 with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713, 800-7714, 800-7715, 800-7101, 800-7102, 800-3938, 800-7157