BD Synapsys Microbiology Informatics Solution — Class II medical device recall Z-1018-2022
Terminated recall by Becton Dickinson & Co., reported 2022-05-11, distributed nationwide. When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the custome
| Recall number | Z-1018-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2022-03-09 |
| Classified | 2022-04-29 |
| Reported by FDA | 2022-05-11 |
| Terminated | 2024-01-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, DE, FR, NL, SE |
| Quantity | 15 systems |
| UPC / GTIN / UDI-DI | 00382904441500 |
| Serial numbers | SL00001, SL000015, SL00002, SL00003, SL00004, SL00005, SL00010, SL00502, SL00509, SL00515, SL00527, SL00530, SL00540, SL00549, SL00564, SL01010, SL01022 |
| Model numbers | 444150 |
Product
BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
Reason for recall
When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes.
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-1018-2022. 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.