Automate 2500 Family
AutoMate2550 – High Speed Sorter with Aliquot Module
7manufacturers in China registered for this device type
4catalogue numbers in this listing
21recalls on this code
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 | Beckman Coulter, Inc., 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, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-08-15 |
| Record revised | 2022-09-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Handling environment humidity 10 to 95 % RH; Handling environment temperature -4 to 140 °F; Storage environment humidity 40 to 80 % RH; Storage environment temperature 64 to 89 °F; Special storage condition: Altitude Must not exceed 6,562 ft |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AutoMate 2500 | In distribution | |
| AutoMate 1200 | In distribution | |
| AutoMate 1250 | In distribution | |
| AutoMate 2550 | 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
7 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-04-08 | Class II | Software design | Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or left empty, REMISOL Advance may incorrectly identify a pati | 1,805 systems | |
| 2021-07-15 | Class II | Software design | There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result. | 180 units | 2024-06-04 |
| 2021-06-23 | Class II | Under Investigation by firm | Software anomalies that may lead to the generation of erroneous results. | 1,085 (482 US & 603 OUS) | 2026-07-02 |
| 2018-11-09 | Class II | Other | Beckman Coulter has identified a case where a customer using the microltiterplate kit option without a sorting drive encountered a cross-contamination of samples when a connection time-out occurred between the system and Laboratory Informat | 83 automate systems | |
| 2018-09-17 | Class II | Software Manufacturing/Software Deployment | Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The compatibility issue causes the software to be unusable which could result in a delay of reporting results. | 41 units | |
| 2018-05-24 | Class III | Software change control | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of barcodes. When printing consecutively numbered tube labels using this optional | 14 | 2022-12-08 |
| 2018-05-24 | Class III | Software change control | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of barcodes.Sorting Drive software version 4.2 was replaced by 4.2.1 (both versions | 58 | 2022-12-08 |
| 2018-05-24 | Class III | Software change control | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of barcodes. When printing consecutively numbered tube labels using this optional | 29 | 2022-12-08 |
| 2018-05-24 | Class III | Software change control | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which included the Sorting-Drive Client that is used for manual printing of barcodes; version 4.2 was replaced by 4.2.1 (they both contain the same opti | 54 | 2022-12-08 |
| 2018-05-24 | Class III | Software change control | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of barcodes. Sorting Drive software version 4.2 was replaced by 4.2.1 (both version | 283 | 2022-12-08 |
| 2018-05-24 | Class III | Software change control | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of barcodes. Sorting Drive software version 4.2 was replaced by 4.2.1 (both version | 495 | 2022-12-08 |
| 2018-05-24 | Class III | Software change control | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which included the Sorting-Drive Client that is used for manual printing of barcodes. When printing consecutively numbered tube labels using this optiona | 25 | 2022-12-08 |
| 2018-01-19 | Class II | Device Design | Belts on the x-axis (and on the y-axis, to a lesser extent) manufactured from 2015 are showing premature failure, posing the remote risk of cross-contamination. | 98 units in the US | |
| 2018-01-18 | Class II | Device Design | A misaligned pipette tip sensor poses the remote risk of cross-contamination when failing to cause a no-tip error, resulting in pipetting patient samples without pipette tips. | 73 units in US | 2023-09-27 |
| 2016-12-21 | Class III | Under Investigation by firm | Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10. | 4 units | 2017-05-17 |
| 2006-11-01 | Not classified | Other | The firm has confirmed that the ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. This issue is limited to only protocols utilizing the Rati | 28 units | 2012-02-27 |
| 2005-08-10 | Not classified | Other | Potentail for misidentification of historical patient results within the Aqueduct Hematology Workflow Manager software. In instances where the workflow manager software receives the same patient identifier for more than one patient the Aque | 36 | 2012-04-03 |
| 2005-06-20 | Not classified | Other | Version v6.4.109f, any result designated as ‘calculated chemistry’ at DL2000 may upload to the LIS with an incorrect or blank sample ID. | 287 | 2011-10-06 |
| 2004-11-05 | Not classified | Other | Possibility of reporting an incorrect result occurs due to a software anomally. | 3 | 2005-03-16 |
| 2003-09-29 | Not classified | Other | Motor driver boards may contain wrong type of microchip which does not have obstruction detection feature. | 351 | 2004-04-05 |
| 2003-09-18 | Not classified | Other | Sample wheel may home to the wrong position. | 154 | 2004-03-30 |
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.