# FDA recall Z-0491-2019

> **Becton Dickinson & Company** · Class II · device recall initiated 2018-08-30.

## Product

BD Vacutainer Urine Collection Cups, Cat. No. 364941

## Reason for recall

BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical Practice (GCP) by using microscopy to confirm an elevated RBC Count in a Urine sample as per CLSI GP16-3A. 29(4) and CAP Checklist on Urinalysis. Product will continue to ship to not impact critical patient care.

## Distribution

Illinois

## Key facts

- **Recall number:** Z-0491-2019
- **Recalling firm:** Becton Dickinson & Company
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-30
- **Report date:** 2018-11-28
- **Termination date:** 2020-10-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Franklin Lakes, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0491-2019

## Citation

> AI Analytics. FDA recall Z-0491-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0491-2019. Source: US FDA. Licensed CC0.

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