BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage:… — Class II medical device recall Z-1051-2019
Terminated recall by Becton Dickinson & Co., reported 2019-04-03, distributed nationwide. BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record
| Recall number | Z-1051-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2019-02-21 |
| Classified | 2019-03-22 |
| Reported by FDA | 2019-04-03 |
| Terminated | 2020-04-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | NL |
| Quantity | 5 sites |
| UPC / GTIN / UDI-DI | 00382904441500 |
| Model numbers | 444150 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1051-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.