FDA-Device2020-01-29Class II
iChem VELOCITY Urine Chemistry Analyzer
Beckman Coulter Inc.
Hazard
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.
Sold states
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, Germany, Ghana, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Macau, Malaysia, Maldives, Mexico, Moldova, Montenegro, Morocco, Netherlands, Netherlands Antillean, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam.
Affected count
4314 units
Manufactured in
250 S Kraemer Blvd, Brea, CA, United States
Products
iChem VELOCITY Urine Chemistry Analyzer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0843-2020Don't want to check this manually?
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