# FDA recall Z-2357-2020

> **Becton, Dickinson and Company, BD Biosciences** · Class II · device recall initiated 2019-07-08.

## Product

BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

## Reason for recall

The recalling firm confirmed that SPA II and III users may  encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use (IFU).  When the probe is worn, particles from the rubber cap are more likely to clog the probe, resulting in blocked or inadequate sample dispense.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of AL, CO,CT, GA, IL,  MA, MI, MD, NC, NH,NJ,  NY,  OH,  PA, TN, TX,  VA, and VT.  The countries of Australia, Botswana, Brazil, Canada, Chile, China, Colombia, Costa Rica, Europe, Hong Kong, India, Italy, Jamaica, Japan, Kazakhstan, Malaysia, Martinique, Mexico, New Zealand, Nicaragua, Peru, Puerto Rico (US), Romania, Russia, Singapore, South Africa, South Korea, Swaziland, Switzerland, Turkey, US, Vietnam.

## Key facts

- **Recall number:** Z-2357-2020
- **Recalling firm:** Becton, Dickinson and Company, BD Biosciences
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-08
- **Report date:** 2020-06-17
- **Termination date:** 2023-01-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2357-2020

## Citation

> AI Analytics. FDA recall Z-2357-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2357-2020. Source: US FDA. Licensed CC0.

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