# FDA recall Z-1894-2018

> **Beckman Coulter Inc.** · Class II · device recall initiated 2018-03-29.

## Product

iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001.     The iChemVELOCITY automated urine chemistry system is an in-vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in a iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems.

## Reason for recall

The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.

## Distribution

US Distribution to states of: AL, IA, GA, and FL.

## Key facts

- **Recall number:** Z-1894-2018
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-29
- **Report date:** 2018-05-30
- **Termination date:** 2019-06-27

- **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-1894-2018

## Citation

> AI Analytics. FDA recall Z-1894-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1894-2018. Source: US FDA. Licensed CC0.

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