510(k) · Cleared
Recalled · Class II · 2025Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Cleared on Nov 10, 2022 as substantially equivalent to K153651 (Beckman Coulter, Inc., 2016) and 1 other predicate after a 196-day review. Its family tree reaches back 2 generations to 1992. It has been recalled 18 times.
- Decided
- Nov 10, 2022
- Review
- 196 days
- Class
- Class II
- Product code
- JLW
- Recalls
- 18
- Predicates
- 2
Its longest line of descent runs back 2 generations to K922823 (1992). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK922823 Access Theophylline Immunoassay ReagentsBio-Rad Laboratories, Inc. · 1992 · Recalled
- 1 generation backK121214 Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on…Beckman Coulter, Inc. · 2013 · Recalled
- This deviceK221225 Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922823 | Access Theophylline Immunoassay Reagents | Bio-Rad Laboratories, Inc. | 1992 | 19 |
| −1 | K121214 | Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on the… | Beckman Coulter, Inc. | 2013 | 5 |
| 0 (this device) | K221225 | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer | Beckman Coulter, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JLW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JLW device
- #1 K251543 Atellica® IM TSH3-Ultra II (TSH3ULII)score 11.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K153651 | Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay…Summary page 4…mistry analyzer for clinical use Classification Regulation:21 CFR 862.2160 Classification Product Code: JJE Predicate Devices: Access TSH (3rd IS) Assay, 510(k) Number k153651 Access 2 Immunoassay System, 510(k) Number k121214… | 2016 |
| * | K121214 | Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on the Access 2…Summary page 4…ulation:21 CFR 862.2160 Classification Product Code: JJE Predicate Devices: Access TSH (3rd IS) Assay, 510(k) Number k153651 Access 2 Immunoassay System, 510(k) Number k121214 1|Page TSH (3rd IS) 510k === Page 5… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 19, 2025 | Class II | Z-0216-2026 | Software design | Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for… |
| May 7, 2025 | Class II | Z-1996-2025 | 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… |
| Apr 23, 2025 | Class II | Z-1913-2025 | Software design | A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay. |
| Apr 23, 2025 | Class II | Z-1926-2025 | Nonconforming Material/Component | A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the assay from being… |
| Mar 27, 2025 | Class II | Z-1664-2025 | 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… |
| Feb 6, 2025 | Class II | Z-1387-2025 | 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… |
| Feb 5, 2025 | Class II | Z-1388-2025 | 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. |
| Nov 13, 2024 | Class II | Z-1326-2025 | 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… |
| Aug 28, 2024 | Class II | Z-0094-2025 | Under Investigation by firm | Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results. |
| Jul 12, 2024 | Class II | Z-1529-2025 | 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. |
| Jul 10, 2024 | Class II | Z-3180-2024 | 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… |
| Jun 4, 2024 | Class II | Z-2414-2024 | 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. |
| Apr 18, 2024 | Class II | Z-0025-2025 | 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… |
| Apr 18, 2024 | Class II | Z-2264-2024 | 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… |
| Mar 5, 2024 | Class II | Z-1546-2024 | 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… |
| Jan 3, 2024 | Class II | Z-1115-2025 | Software design | A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results. |
| Nov 21, 2023 | Class II | Z-0982-2024 | 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… |
| Sep 12, 2023 | Class II | Z-0107-2024 | 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… |
The 5 latest of 18 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 20.9 years on median.
- 3 of the 4 ancestors have a recall of any class.
How does its category compare?
All JLW devicesJLW Radioimmunoassay, Thyroid-Stimulating Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · JLW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JLW
194in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JLW
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JLW
103in 2025
MAUDE reports naming product code JLW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 19 |
| 2008 | 5 | 143 | 0 | 10 |
| 2009 | 2 | — | 0 | 41 |
| 2010 | 1 | — | 1 | 34 |
| 2011 | 0 | — | 1 | 167 |
| 2012 | 1 | — | 3 | 144 |
| 2013 | 1 | — | 0 | 168 |
| 2014 | 1 | — | 0 | 155 |
| 2015 | 3 | 142 | 0 | 203 |
| 2016 | 3 | 238 | 1 | 183 |
| 2017 | 4 | 194 | 0 | 235 |
| 2018 | 0 | — | 4 | 249 |
| 2019 | 1 | — | 1 | 216 |
| 2020 | 0 | — | 2 | 145 |
| 2021 | 0 | — | 0 | 146 |
| 2022 | 1 | — | 0 | 137 |
| 2023 | 1 | — | 0 | 162 |
| 2024 | 2 | — | 2 | 169 |
| 2025 | 1 | — | 2 | 103 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. This assay is capable of providing 3rd generation TSH results.
The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221225: Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221225
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026