ClearanceBrief
Panels › Clinical Chemistry › Product code JJE · Class 1

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Regulation 862.2160

0510(k)s in 12 months (208 all time)
12recalls in 12 months (564 all time)
494recalls that name a 510(k)
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Top companies in JJE

Company510(k)sRecalls
Beckman Coulter, Inc.1146
Ortho-Clinical Diagnostics, Inc.1130
Siemens Healthcare Diagnostics288
Abbott Laboratories1357
Roche Diagnostics Corp.042
Roche Diagnostics Operations, Inc.028
Eastman Kodak Company180
Boehringer Mannheim Corp.160
Abbott Gmbh & Co. KG014
Beckman Instruments, Inc.90
DateFirm and productCodeLinked 510(k)
Oct 2, 2026Beckman Coulter Inc.
DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
Open, Classified		 JJEK220977
Oct 2, 2026Beckman Coulter Inc.
DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module, DxC 500i, Part No. C13252
Open, Classified		 JJEK242190
Oct 1, 2026Beckman Coulter Mishima K.K.
Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965 B96693 / 14987666542972 B12183 / 14987666540671 The AU480 Chemistry
Open, Classified		 JJEK981743
Aug 17, 2026Beckman Coulter Inc.
Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analyze
Open, Classified		 JJEK220977
Aug 17, 2026Beckman Coulter Inc.
Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521;
Open, Classified		 JJEK242190
Feb 27, 2026Roche Diagnostics Operations, Inc.
cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name
Open, Classified		 JJEK191899
Jan 6, 2026Beckman Coulter, Inc.
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Open, Classified		 JJEK121790
Jan 6, 2026Beckman Coulter, Inc.
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Open, Classified		 JJEK121790
Dec 18, 2025Abbott Laboratories
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Open, Classified		 JJEK170316
K170317
Dec 9, 2025Beckman Coulter, Inc.
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901
Open, Classified		 JJEK121214
Nov 4, 2025Beckman Coulter, Inc.
Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer
Open, Classified		 JJEK121790
Nov 4, 2025Beckman Coulter, Inc.
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
Open, Classified		 JJEK121790
Aug 5, 2025Beckman Coulter, Inc.
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
Open, Classified		 JJEK023764
Aug 5, 2025Beckman Coulter, Inc.
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
Open, Classified		 JJEK023764
Aug 5, 2025Beckman Coulter, Inc.
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
Open, Classified		 JJEK023764
Aug 5, 2025Beckman Coulter, Inc.
DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
Open, Classified		 JJEK023764
Aug 5, 2025Beckman Coulter, Inc.
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
Open, Classified		 JJEK023764
Aug 5, 2025Beckman Coulter, Inc.
UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100
Open, Classified		 JJEK023764
Jun 27, 2025Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product De
Open, Classified		 JJEK031924
Jun 27, 2025Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Pr
Open, Classified		 JJEK182063
Jun 27, 2025Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915
Open, Classified		 JJEK081543
Jun 25, 2025Siemens Healthcare Diagnostics, Inc.
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Open, Classified		 JJEK151767
Jun 20, 2025Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer C11137
Open, Classified		 JJEK221225
Jun 4, 2025Beckman Coulter Mishima K.K.
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
Completed		 JJEK961274
May 27, 2025Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.
Open, Classified		 JJENone listed
May 15, 2025Beckman Coulter Inc.
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistr
Open, Classified		 JJEK220977
Apr 25, 2025Beckman Coulter Inc.
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3 The Beckman Coulter DxC 500 A
Open, Classified		 JJEK220977
Apr 24, 2025Beckman Coulter, Inc.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Open, Classified		 JJEK221225
Apr 4, 2025Beckman 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		 JJEK221225
Apr 3, 2025Beckman Coulter Inc.
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry
Open, Classified		 JJENone listed
Mar 17, 2025Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278
Open, Classified		 JJEK221225
Mar 17, 2025Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
Open, Classified		 JJEK221225
Mar 17, 2025Beckman Coulter, Inc.
Access 2 Immunoassay Analyzer, Catalog Number 81600N
Open, Classified		 JJEK121214
Mar 12, 2025Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
Open, Classified		 JJEK221225
Feb 25, 2025BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Open, Classified		 JJEK220977
Feb 6, 2025Beckman Coulter, Inc.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Completed		 JJEK221225
Jan 21, 2025Ortho-Clinical Diagnostics, INc.
Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Pro
Open, Classified		 JJEK083173
Jan 21, 2025Ortho-Clinical Diagnostics, INc.
Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Descriptio
Open, Classified		 JJEK182063
Jan 21, 2025Ortho-Clinical Diagnostics, INc.
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Product D
Open, Classified		 JJEK081543
Dec 4, 2024Siemens Healthcare Diagnostics, Inc.
Atellica CI Analyzer. Catalog Numbers: 10947347.
Open, Classified		 JJEK222116
Nov 20, 2024Siemens Healthcare Diagnostics, Inc.
Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Number(SMN): 11099326 A
Open, Classified		 JJEK161954
Oct 7, 2024Beckman 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		 JJEK221225
Sep 19, 2024Beckman 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		 JJEK221225
Aug 30, 2024Beckman 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		 JJEK221225
Aug 27, 2024Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Open, Classified		 JJENone listed
Aug 21, 2024Beckman Coulter Mishima K.K.
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) ma
Open, Classified		 JJEK220977
Aug 9, 2024Beckman Coulter, Inc.
Discrete photometric chemistry analyzer for clinical use.
Open, Classified		 JJENone listed
Aug 9, 2024Beckman Coulter, Inc.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Open, Classified		 JJENone listed
Jul 31, 2024Beckman Coulter Mishima K.K.
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) ma
Open, Classified		 JJEK220977
Jul 23, 2024Beckman Coulter, Inc.
Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
Open, Classified		 JJEK221225

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