# K221225: Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Nov 10, 2022 after 196 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- Recalls of this device: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K922823 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153651: Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems, Beckman Coulter, Inc. (2016) Summary page 4.
- K121214: Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on the Access 2 Immunoassay System, Beckman Coulter, Inc. (2013) Summary page 4.

## Recalls of this device
- Sep 19, 2025 · Class II · Z-0216-2026: 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 facto
- May 7, 2025 · Class II · Z-1996-2025: 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 mis
- Apr 23, 2025 · Class II · Z-1913-2025: 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 re
- Apr 23, 2025 · Class II · Z-1926-2025: 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
- Mar 27, 2025 · Class II · Z-1664-2025: 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 
- Feb 6, 2025 · Class II · Z-1387-2025: 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 failur
- Feb 5, 2025 · Class II · Z-1388-2025: 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 resu
- Nov 13, 2024 · Class II · Z-1326-2025: 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 Dispen
- Aug 28, 2024 · Class II · Z-0094-2025: Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.
- Jul 12, 2024 · Class II · Z-1529-2025: 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: 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 erro
- Jun 4, 2024 · Class II · Z-2414-2024: 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 communi
- Apr 18, 2024 · Class II · Z-0025-2025: 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 expire
- Apr 18, 2024 · Class II · Z-2264-2024: 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 co
- Mar 5, 2024 · Class II · Z-1546-2024: 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 resul
- Jan 3, 2024 · Class II · Z-1115-2025: 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: 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 convers
- Sep 12, 2023 · Class II · Z-0107-2024: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K221225
Methodology: https://510kreport.com/methodology