# FDA recall Z-2099-2023

> **Becton Dickinson & Co.** · Class II · device recall initiated 2023-06-08.

## Product

BD Synapsys Informatics Solution, Catalog Number 444150

## Reason for recall

There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operating near capacity and are using save actions (Skip, Final Discard, Mark as Read, Save) to process patient results rapidly.

## Distribution

US States: CA, CO, IA, IL, MI, MN, MO, NY, OH, OK, SC, TN, TX, UT, WI.  Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom

## Key facts

- **Recall number:** Z-2099-2023
- **Recalling firm:** Becton Dickinson & Co.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-08
- **Report date:** 2023-07-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sparks, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2099-2023

## Citation

> AI Analytics. FDA recall Z-2099-2023. Retrieved 2026-08-03 from https://api.ai-analytics.org/recall/Z-2099-2023. Source: US FDA. Licensed CC0.

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