# FDA recall Z-1893-2018

> **Beckman Coulter Inc.** · Class II · device recall initiated 2017-12-04.

## Product

iChem VELOCITY Urine Chemistry Strips, REF 800-7212    Product Usage:  The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. The iChem VELOCITY can be used as a stand alone-system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi- quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones, and ascorbic acid; and qualitative results for nitrites, color, and clarity. iChem VELOCITY strips are intended for use with the iCHEM VELOCITY analyzer. In particular they are not intended for visual reading. The iChem VELOCITY test strips are not intended for visual reading. The iChem VELOCITY is not intended to be used as a Point of Care (POC)

## Reason for recall

A subset of Lot  7212154 A  of the iChem VELOCITY Urine Chemistry strips has an incorrect pad placed in the location of the leukocytes pad. This will result in control CB failure for leukocytes and may generate false negative erroneous results for leukocytes.

## Distribution

Worldwide Distribution and US Nationwide Distribution

## Key facts

- **Recall number:** Z-1893-2018
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-04
- **Report date:** 2018-05-23
- **Termination date:** 2023-05-30

- **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-1893-2018

## Citation

> AI Analytics. FDA recall Z-1893-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1893-2018. Source: US FDA. Licensed CC0.

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