BD Synapsys™ Informatics Solution
2 catalogue numbers from 444150, listed by Becton, Dickinson AND Company, United States, under Calculator/Data Processing Module, For Clinical Use. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Foshan Zike Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 9 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
| Shanghai Bestcovered Limited | Shanghai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Becton, Dickinson AND Company, United States |
|---|---|
| FDA product code | JQP |
| Device type | Calculator/Data Processing Module, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2100 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-04-03 |
| Record revised | 2024-11-01 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Special storage condition: Room Temperature |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 444150 | In distribution | |
| 444139 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SoftPathDx | SCC Soft Computer | 69 |
| SoftMolecular | SCC Soft Computer | 67 |
| SoftFlowCytometry | SCC Soft Computer | 67 |
| SoftBiochemistry | SCC Soft Computer | 67 |
| SoftCytogenetics | SCC Soft Computer | 67 |
| SoftMic | SCC Soft Computer | 65 |
| SoftLab | SCC Soft Computer | 64 |
| SoftTrack | SCC Soft Computer | 61 |
| SoftHLA | SCC Soft Computer | 61 |
| SoftGenomics | SCC Soft Computer | 51 |
| SoftGenePortal | SCC Soft Computer | 48 |
| SoftTotalQC | SCC Soft Computer | 28 |
Showing 12 of 140. All products under Calculator/Data Processing Module, For Clinical Use
Recalls Naming This Product
5 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | UDI-DI | 2024-10-31 | Class II | Software design | BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized | 56 units (OUS only) | |
| Becton, Dickinson & Co. | UDI-DI | 2024-09-12 | Class II | Under Investigation by firm | Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectly display breakpoints for organisms that do not have defined breakpoints in CLSI | 162 units | |
| Becton, Dickinson & Co. | UDI-DI | 2023-06-08 | Class II | Software design | 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, S | 102 systems | |
| Becton, Dickinson & Co. | UDI-DI | 2022-03-09 | Class II | Under Investigation by firm | 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. | 15 systems | 2024-01-19 |
| Becton, Dickinson & Co. | UDI-DI | 2019-02-21 | Class II | Software design | BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record. | 5 sites | 2020-04-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.