Beckman Coulter Inc. recalls iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103,

Recalled March 8, 2017 · FDA recall Z-1384-2017 · Beckman Coulter

Hazard

The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient results. · FDA Class II

Units

3175 units total (1697 units in US)

Sold at

Worldwide Distribution - US (nationwide) and internationally to Argentina, Australia, Austria, Bangladesh, Belarus, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Canada, Chile, China, Columbia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Macau, Malaysia, Mexico, Moldova, Montenegro, Netherlands, New Zealand, Nigeria, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Republic and Venezuela.

Description

The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient results.

Product

iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose, bilirubin, urobilinogen, nitrite, leukocyte esterase, specific gravity, pH, ascorbic acid, color, and clarity. The iChem Velocity automated urine chemistry analyzer is intended to be used for in vitro measurement of various analytes in urine; it is intended for use only with the iChem Velocity urine chemistry strips

Manufacturer(s)

Beckman Coulter Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →