510(k) K221225 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Nov 10, 2022 |
| Received | Apr 28, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221225
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2025 | Beckman Coulter, Inc. DxI 9000 Access Immunoassay Analyzer, Part Number C11137 Open, Classified |
JLW | None listed |
| Jun 20, 2025 | Beckman Coulter, Inc. DxI 9000 Access Immunoassay Analyzer C11137 Open, Classified |
JJE | None listed |
| Jun 6, 2025 | Beckman Coulter, Inc. DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20 Open, Classified |
JLW | None listed |
| Jun 5, 2025 | Beckman Coulter, Inc. DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20 Open, Classified |
JLW | None listed |
| Apr 24, 2025 | Beckman Coulter, Inc. Beckman Coulter DxI 9000 Access Immunoassay Analyzer Open, Classified |
JJE | None listed |
| Apr 4, 2025 | Beckman Coulter, Inc. DxI 9000 Access Immunoassay Analyzer, catalog number C11137
in vitro diagnostic
device used for the quantitative, semi-quantitative, or qualitative
determination of various analyte concentrations fou Open, Classified |
JJE | None listed |
| Mar 17, 2025 | Beckman Coulter, Inc. DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137. Open, Classified |
JJE | None listed |
| Mar 17, 2025 | Beckman Coulter, Inc. DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278 Open, Classified |
JJE | None listed |
| Mar 12, 2025 | Beckman Coulter, Inc. DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137 Open, Classified |
JJE | None listed |
| Feb 6, 2025 | Beckman Coulter, Inc. Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument Completed |
JJE | None listed |
| Oct 16, 2024 | Beckman Coulter, Inc. The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human Open, Classified |
JLW | None listed |
| Oct 7, 2024 | Beckman Coulter, Inc. Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentra Open, Classified |
JJE | None listed |
| Sep 19, 2024 | Beckman Coulter, Inc. Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument Open, Classified |
JJE | None listed |
| Aug 30, 2024 | Beckman Coulter, Inc. DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human bo Open, Classified |
JJE | None listed |
| Jul 23, 2024 | Beckman Coulter, Inc. Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137. Open, Classified |
JJE | None listed |
| Jul 3, 2024 | Beckman Coulter, Inc. DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic Open, Classified |
JJE | None listed |
| Feb 5, 2024 | Beckman Coulter, Inc. DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior, Open, Classified |
JJE | None listed |
| Oct 12, 2023 | Beckman Coulter, Inc. DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic Open, Classified |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.