| REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the fol recall (Z-2888-2026) | Beckman Coulter Inc. | 2026-08-05 |
| REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instrum recall (Z-2889-2026) | Beckman Coulter Inc. | 2026-08-05 |
| Access Total T4 Calibrator, Catalog No. 33805 recall (Z-1922-2026) | Beckman Coulter, Inc. | 2026-04-22 |
| MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Us recall (Z-1794-2026) | Beckman Coulter, Inc. | 2026-04-08 |
| MicroScan Neg MIC 3J REF C54814 recall (Z-1772-2026) | Beckman Coulter, Inc. | 2026-04-03 |
| MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed recall (Z-1609-2026) | Beckman Coulter, Inc. | 2026-03-20 |
| CellMek SPS Sample Preparation System, REF: C44603, with software recall (Z-1235-2026) | Beckman Coulter, Inc. | 2026-02-02 |
| COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic recall (Z-1221-2026) | Beckman Coulter, Inc. | 2026-01-30 |
| Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, recall (Z-1025-2026) | Beckman Coulter, Inc. | 2026-01-06 |
| Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay recall (Z-1026-2026) | Beckman Coulter, Inc. | 2026-01-06 |
| Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, recall (Z-0889-2026) | Beckman Coulter, Inc. | 2025-12-09 |
| DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cy recall (Z-0541-2026) | Beckman Coulter Inc. | 2025-11-18 |
| SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 recall (Z-0441-2026) | Beckman Coulter Inc. | 2025-11-06 |
| Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyz recall (Z-0428-2026) | Beckman Coulter, Inc. | 2025-11-04 |
| Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyz recall (Z-0429-2026) | Beckman Coulter, Inc. | 2025-11-04 |
| CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, recall (Z-0412-2026) | Beckman Coulter, Inc. | 2025-10-30 |
| DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522) recall (Z-0215-2026) | Beckman Coulter, Inc. | 2025-10-21 |
| DxI 9000 Access Immunoassay Analyzer, Part Number C11137 recall (Z-0216-2026) | Beckman Coulter, Inc. | 2025-10-21 |
| SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx On recall (Z-0071-2026) | Beckman Coulter Inc. | 2025-10-08 |
| DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, recall (Z-0032-2026) | Beckman Coulter Inc. | 2025-10-02 |
| UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer RE recall (Z-2572-2025) | Beckman Coulter Inc. | 2025-09-17 |
| UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer R recall (Z-2573-2025) | Beckman Coulter Inc. | 2025-09-17 |
| UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer RE recall (Z-2574-2025) | Beckman Coulter Inc. | 2025-09-17 |
| UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer RE recall (Z-2575-2025) | Beckman Coulter Inc. | 2025-09-17 |
| Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number recall (Z-2322-2025) | Beckman Coulter, Inc. | 2025-08-13 |
| UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100 recall (Z-2266-2025) | Beckman Coulter, Inc. | 2025-08-05 |
| DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457 recall (Z-2267-2025) | Beckman Coulter, Inc. | 2025-08-05 |
| DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456 recall (Z-2268-2025) | Beckman Coulter, Inc. | 2025-08-05 |
| UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260 recall (Z-2269-2025) | Beckman Coulter, Inc. | 2025-08-05 |
| DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461 recall (Z-2270-2025) | Beckman Coulter, Inc. | 2025-08-05 |
| DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460 recall (Z-2271-2025) | Beckman Coulter, Inc. | 2025-08-05 |
| UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205, recall (Z-2264-2025) | Beckman Coulter Inc. | 2025-08-04 |
| Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of recall (Z-2152-2025) | Beckman Coulter Inc. | 2025-07-21 |
| Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850 recall (Z-2115-2025) | Beckman Coulter, Inc. | 2025-07-11 |
| REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; recall (Z-2028-2025) | Beckman Coulter Inc. | 2025-06-25 |
| DxI 9000 Access Immunoassay Analyzer C11137 recall (Z-1996-2025) | Beckman Coulter, Inc. | 2025-06-20 |
| DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.2 recall (Z-1926-2025) | Beckman Coulter, Inc. | 2025-06-06 |
| DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20 recall (Z-1913-2025) | Beckman Coulter, Inc. | 2025-06-05 |
| Access Testosterone assay, Catalog Number 33560 recall (Z-1901-2025) | Beckman Coulter, Inc. | 2025-06-02 |
| DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 recall (Z-1784-2025) | Beckman Coulter Inc. | 2025-05-15 |
| DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 recall (Z-1672-2025) | Beckman Coulter Inc. | 2025-04-25 |
| Beckman Coulter DxI 9000 Access Immunoassay Analyzer recall (Z-1664-2025) | Beckman Coulter, Inc. | 2025-04-24 |
| DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device use recall (Z-1529-2025) | Beckman Coulter, Inc. | 2025-04-04 |
| DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 recall (Z-1517-2025) | Beckman Coulter Inc. | 2025-04-03 |
| Access 2 Immunoassay Analyzer, Catalog Number 81600N recall (Z-1386-2025) | Beckman Coulter, Inc. | 2025-03-17 |
| DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI f recall (Z-1387-2025) | Beckman Coulter, Inc. | 2025-03-17 |
| DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137. recall (Z-1388-2025) | Beckman Coulter, Inc. | 2025-03-17 |
| DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137 recall (Z-1326-2025) | Beckman Coulter, Inc. | 2025-03-12 |
| Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) prod recall (Z-1249-2025) | Beckman Coulter, Inc. | 2025-02-28 |
| Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diag recall (Z-1115-2025) | Beckman Coulter, Inc. | 2025-02-06 |
| Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immun recall (Z-1112-2025) | Beckman Coulter Inc. | 2025-02-05 |
| Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the qua recall (Z-0803-2025) | Beckman Coulter, Inc. | 2025-01-03 |
| Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitati recall (Z-0727-2025) | Beckman Coulter, Inc. | 2024-12-20 |
| Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972 recall (Z-0673-2025) | Beckman Coulter Inc. | 2024-12-11 |
| The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the recall (Z-0313-2025) | Beckman Coulter, Inc. | 2024-11-06 |
| Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14 recall (Z-0265-2025) | Beckman Coulter, Inc. | 2024-10-30 |
| IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when u recall (Z-0118-2025) | Beckman Coulter Inc. | 2024-10-17 |
| Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and recall (Z-0093-2025) | Beckman Coulter, Inc. | 2024-10-16 |
| The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for recall (Z-0094-2025) | Beckman Coulter, Inc. | 2024-10-16 |
| Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic recall (Z-0025-2025) | Beckman Coulter, Inc. | 2024-10-07 |
| Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic T recall (Z-3180-2024) | Beckman Coulter, Inc. | 2024-09-19 |
| DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the qua recall (Z-1546-2024) | Beckman Coulter, Inc. | 2024-08-30 |
| DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. recall (Z-2735-2024) | Beckman Coulter, Inc. | 2024-08-27 |
| Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. recall (Z-2544-2024) | Beckman Coulter, Inc. | 2024-08-09 |
| Discrete photometric chemistry analyzer for clinical use. recall (Z-2545-2024) | Beckman Coulter, Inc. | 2024-08-09 |
| Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2 recall (Z-2428-2024) | Beckman Coulter Inc. | 2024-07-24 |
| Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137. recall (Z-2414-2024) | Beckman Coulter, Inc. | 2024-07-23 |
| DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic recall (Z-2264-2024) | Beckman Coulter, Inc. | 2024-07-03 |
| Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry a recall (Z-2237-2024) | Beckman Coulter, Inc. | 2024-06-28 |
| Access Substrate, REF 81906, For use with the Access Immunoassay Systems recall (Z-1376-2024) | Beckman Coulter, Inc. | 2024-03-25 |
| Access Total T4, REF 33800, IVD, thyroxine reagent assay. recall (Z-1303-2024) | Beckman Coulter, Inc. | 2024-03-15 |
| Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catal recall (Z-0981-2024) | Beckman Coulter, Inc. | 2024-02-05 |
| DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior, recall (Z-0982-2024) | Beckman Coulter, Inc. | 2024-02-05 |
| Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947 recall (Z-0784-2024) | Beckman Coulter, Inc. | 2024-01-25 |
| iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-33 recall (Z-0785-2024) | Beckman Coulter, Inc. | 2024-01-25 |
| REV 2 Flowcell Capsule Spare, Part Number: C04154 recall (Z-0786-2024) | Beckman Coulter, Inc. | 2024-01-25 |
| iQ Waste Well Adapter, Part Number: 700-3393 recall (Z-0787-2024) | Beckman Coulter, Inc. | 2024-01-25 |
| DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro recall (Z-0107-2024) | Beckman Coulter, Inc. | 2023-10-12 |
| Access Thyroglobulin Calibrators recall (Z-0100-2024) | Beckman Coulter, Inc. | 2023-10-11 |
| Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2 recall (Z-2488-2023) | Beckman Coulter Inc. | 2023-08-31 |
| Ringed DxI Reaction Vessels (RVs) recall (Z-2237-2023) | Beckman Coulter, Inc. | 2023-07-26 |
| COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells recall (Z-2138-2023) | Beckman Coulter, Inc. | 2023-07-12 |
| Access Hybritech p2PSA reagent, REF B03704 and REF A49752. recall (Z-2043-2023) | Beckman Coulter, Inc. | 2023-06-30 |
| Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL recall (Z-1606-2023) | Beckman Coulter Inc. | 2023-05-18 |
| Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL recall (Z-1607-2023) | Beckman Coulter Inc. | 2023-05-18 |
| Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL recall (Z-1608-2023) | Beckman Coulter Inc. | 2023-05-18 |
| iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345 recall (Z-1596-2023) | Beckman Coulter, Inc. | 2023-05-17 |
| DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, recall (Z-1597-2023) | Beckman Coulter, Inc. | 2023-05-17 |
| DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device recall (Z-1598-2023) | Beckman Coulter, Inc. | 2023-05-17 |
| UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis recall (Z-1599-2023) | Beckman Coulter, Inc. | 2023-05-17 |
| Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains recall (Z-1419-2023) | Beckman Coulter, Inc. | 2023-04-20 |
| Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immuno recall (Z-1257-2023) | Beckman Coulter, Inc. | 2023-03-15 |
| BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only. recall (Z-0777-2023) | Beckman Coulter, Inc. | 2023-01-03 |
| MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280 recall (Z-0269-2023) | Beckman Coulter, Inc. | 2022-11-18 |
| Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 97 recall (Z-0117-2022) | Beckman Coulter Inc. | 2021-10-14 |
| Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880 (UDI:15099 recall (Z-2237-2020) | Beckman Coulter Inc. | 2020-06-02 |
| Beckman Coulter Access Immunoassay Systems, Access Free T3 Triiodothyronine, REF A13422 (U recall (Z-2238-2020) | Beckman Coulter Inc. | 2020-06-02 |
| Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830 ( recall (Z-2239-2020) | Beckman Coulter Inc. | 2020-06-02 |
| Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590 recall (Z-2240-2020) | Beckman Coulter Inc. | 2020-06-02 |
| Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387 recall (Z-2241-2020) | Beckman Coulter Inc. | 2020-06-02 |