DxA 5000
Catalogue number DxA 5000, listed by Beckman Coulter, Inc., United States, under Analyzer, Chemistry (Photometric, Discrete), For Clinical Use. 16 manufacturers in China are registered for this product code.
16manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
40recalls on this code
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (3), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
| Beijing Hotgen Biotech Co., Ltd. | Beijing | Beijing | Manufacturer | 13 |
| Yantai Addcare Bio-Tech Co., Ltd. | Yantai | Shandong | Contract manufacturer | 8 |
| Shenzhen NEW Industries Biomedical Engineering Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Shanghai Kehua Laboratory System Co., Ltd. | Shanghai | Shanghai | Manufacturer | 4 |
Showing 12 of 16. All 16 manufacturers in China registered for Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Record
| Listed by | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | JJE |
| Device type | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2160 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Record published | 2019-11-04 |
| Record revised | 2022-09-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 20 to 80 % RH; Storage environment temperature 16 to 27 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DxA 5000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alinity | Abbott Medical | 283 |
| Architect | Abbott Laboratories | 115 |
| Alinity | Abbott Laboratories | 18 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 15 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 14 |
| Architect | Abbott Ireland Diagnostics | 8 |
| AU | Beckman Coulter, Inc. | 7 |
| Alinity | Abbott Ireland Diagnostics | 6 |
| DxC AU | Beckman Coulter, Inc. | 6 |
| Chemiluminescence Immunoassay Analyzer | Shenzhen Yhlo Biotech Co., Ltd. | 6 |
| Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL300 | Tosoh Corp. | 5 |
| Pictus 500 Clinical chemistry analyzer | Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag | 4 |
Showing 12 of 336. All products under Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K023764 | 2003-01-28 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Beckman Coulter Biomedical GmbH | UDI-DI | 2023-06-02 | Class II | Software design | A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results | 146 systems |
| Beckman Coulter Biomedical GmbH | UDI-DI | 2023-06-02 | Class II | Software design | A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results | 15 |
Recalls
40 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-07-15 | Class II | Software design (manufacturing process) | a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized | ||
| 2026-07-15 | Class II | Software design (manufacturing process) | a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized | ||
| 2025-11-26 | Class II | Device Design | Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be u | 1272 units | |
| 2025-11-26 | Class II | Device Design | Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be u | 6457 units | |
| 2025-11-07 | Class II | Process design | It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrume | 38,225 untis | |
| 2025-10-01 | Class II | Process control | An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obt | 657 units | |
| 2025-10-01 | Class II | Process control | An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obt | 80 units | |
| 2025-06-25 | Class II | Device Design | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (in | 177 systems | |
| 2025-06-25 | Class II | Device Design | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (in | 451 systems | |
| 2025-06-25 | Class II | Device Design | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (in | 1 system | |
| 2025-06-25 | Class II | Device Design | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (in | 2203 systems | |
| 2025-06-25 | Class II | Device Design | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (in | 271 systems | |
| 2025-06-25 | Class II | Device Design | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (in | 1 system | |
| 2025-05-07 | Class II | Software design | Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS | 67 US; 178 OUS | |
| 2025-03-27 | Class II | Software design | When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the | 370 units | |
| 2025-03-20 | Class II | Software design | Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software error causes the analyzer to not run a requested calibration order in the following scenario: when a reagent blank or calibration is ordered durin | ||
| 2025-03-17 | Class II | Under Investigation by firm | The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results. | 136 systems (U.S. 68 and O.U.S. 68) | |
| 2025-02-26 | Class II | Software design | Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are rerun, either manually ordered by the operator at the analyze | 143 systems (U.S. 74 and O.U.S. 69) | |
| 2025-02-06 | Class II | Device Design | Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in a delay | 80 units | |
| 2025-02-05 | Class II | Process design | the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays in patient results. | 206 units | |
| 2025-02-05 | Class II | Nonconforming Material/Component | Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (a | 873 units | |
| 2024-11-13 | Class II | Nonconforming Material/Component | The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displaye | 245 units | |
| 2024-07-12 | Class II | Device Design | Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Smoke also poses a hazard to equipment and users. | 30 OUS | |
| 2024-07-10 | Class II | Nonconforming Material/Component | Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatics Tubing in the reagent storage module causing air leaks, compressor failures or sample processing errors. Four complaints were filed for this | 170 units | |
| 2024-06-14 | Class II | Under Investigation by firm | Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoassay System Analyzers that appear to be caused by misaligned index wheels housed within the reagent carousel module. Customers affected by this | 59 units | |
| 2024-06-04 | Class II | Nonconforming Material/Component | The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed patient results. | 143 devices | |
| 2024-05-22 | Class II | Software design | When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is ful | 183 analyzers | |
| 2024-05-22 | Class II | Software design | The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is s | 183 devices | |
| 2024-04-18 | Class II | Software design | When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibratio | 164 units | |
| 2024-04-18 | Class II | Software design | Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids, | 116 units | |
| 2024-03-05 | Class II | Process control | Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in repor | 17 units | |
| 2024-02-29 | Class II | Under Investigation by firm | The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex cable assembly fittings during normal operation. The DxI 9000 Access Immunoassay An | 9 instruments | |
| 2024-01-03 | Class II | Software design | A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results. | 61 units | |
| 2023-11-21 | Class II | Software design | There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access Ultrasensitive Insulin users who configure SI units (pmol/L) applies an incorrect conversion factor; 2) System provides numerical | 128 analyzers | |
| 2023-09-12 | Class II | Software design | The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with a sample ID that was previously in the same rack and positio | 36 units | |
| 2023-06-20 | Class II | Under Investigation by firm | Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immunoassay System (600, 800 series). The reason for the recall is that the firm has identified 3 lots of RVs that failed an internally used service | 213 cases of 10,000 RVs (2,130,000 RVs) | |
| 2023-01-26 | Class II | Component change control | An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increased volume of complaints from consignees regarding wash arm motion failures, system check failures, and/or assay performance leading to a remote | 4,137 devices (990 U.S. and 3,147 OUS) | |
| 2021-07-21 | Class II | Under Investigation by firm | There is a potential that sample carriers (w or w/o samples) within automated sampling system may transport samples to the outer lane which does not contain a physical barrier to restrain samples. Samples are dropped when they reach the | 123 systems | 2024-10-10 |
| 2019-05-17 | Class II | Software design | Potential exposure to biohazard. Software design problem causes excess speed and vibrations in the unload arm movement which causes caused sample splashing. | 291 units | 2022-03-11 |
| 2018-12-05 | Class II | Under Investigation by firm | When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to | 2842 |
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.