FDA Device recall Z-2099-2023
BD Synapsys Informatics Solution, Catalog Number 444150
- FDA Device
- Class II
- ongoing
- Published 2023-07-12
On 2023-07-12 the FDA classified a Class II recall of BD Synapsys Informatics Solution, Catalog Number 444150 by Becton Dickinson And, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2099-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-08 |
| Published | 2023-07-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Becton Dickinson And |
| Distribution | CA, CO, IA, IL, MI, MN, MO, NY, OH, OK, SC, TN, TX, UT, WI |
Product
BD Synapsys Informatics Solution, Catalog Number 444150
Reason
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.
Identifiers
| code_info | UDI-DI: 00382904441500; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2099-2023%22
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