BD Synapsys Informatics Solution — Class II medical device recall Z-2099-2023
Ongoing recall by Becton Dickinson & Co., reported 2023-07-12, distributed in CA, CO, IA, IL, MI, MN, MO, NY…. There is a risk of mis-association of patient demographic data for users who choose to report results manually
| Recall number | Z-2099-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2023-06-08 |
| Classified | 2023-07-05 |
| Reported by FDA | 2023-07-12 |
| Distributed | CA, CO, IA, IL, MI, MN, MO, NY, OH, OK, SC, TN, TX, UT, WI |
| Countries outside the US | AT, AU, BE, CA, CH, DE, DK, ES, FR, GB, IT, JP, LU, NL, NO, NZ, SA, SE, SG, TW, ZA |
| Quantity | 102 systems |
| UPC / GTIN / UDI-DI | 00382904441500 |
| Model numbers | 444150 |
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.
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-2099-2023. 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.