# FDA recall Z-0843-2020

> **Beckman Coulter Inc.** · Class II · device recall initiated 2019-11-07.

## 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

- **Recall number:** Z-0843-2020
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0843-2020. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0843-2020. Source: US FDA. Licensed CC0.

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