Beckman Coulter Inc. recalls iChem VELOCITY Urine Chemistry Analyzer

Recall date

November 7, 2019

Source

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

Recall number

Z-0843-2020

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

Worldwide Distribution: US (nationwide) including Puerto Rico and countries of: Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Ecuador, France,…

Why it was recalled

Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCITY Urine Chemistry System that prevents the trigger of a chemistry system flag S3 and may result in erroneous Specific Gravity (SG) results.

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

What was recalled

iChem VELOCITY Urine Chemistry Analyzer