FDA recall Z-0843-2020

Product

iChem VELOCITY Urine Chemistry Analyzer

Reason for recall

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.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2019-11-07

Report date

2020-01-29

Termination date

2023-09-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brea, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0843-2020