# FDA recall Z-1051-2019

> **Becton Dickinson & Co.** · Class II · device recall initiated 2019-02-21.

## Product

BD Synapsys Laboratory Solutions   Catalog Number:444150    Product Usage:  BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. The software integrates operational and clinical data points from laboratory hardware, with patient data received from external software systems allowing for the aggregation, evaluation, dissemination of knowledge using all data, anywhere, anytime. Currently Release 2 of BD Synapsys  can connect to both Lab Automation (Kiestra) and BACTEC instruments.

## Reason for recall

BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.

## Distribution

Worldwide Distribution - US: Nationwide in the states of OH, IL, MO, TN and the countries of Netherlands

## Key facts

- **Recall number:** Z-1051-2019
- **Recalling firm:** Becton Dickinson & Co.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-21
- **Report date:** 2019-04-03
- **Termination date:** 2020-04-17

- **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-1051-2019

## Citation

> AI Analytics. FDA recall Z-1051-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1051-2019. Source: US FDA. Licensed CC0.

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