VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM— 510(k) K083173

Clearance details

Applicant

Ortho-Clinical Diagnostics

Product code

Code JLW

Device class

Class 2

Regulation

21 CFR 862.1690

Advisory panel

Clinical Chemistry

Date received

2008-10-27

Decision date

2008-12-22

Decision

Substantially Equivalent

Clearance type

Special

Location

Rochester, NY, US

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Malfunction

885

Total

885

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1007-2025 — 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 Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: no, not a componentClass II·Ongoing·Ortho-Clinical Diagnostics, INc.·20241219
• Z-1224-2024 — VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)Class II·Ongoing·Ortho-Clinical Diagnostics, Inc.·20240126
• Z-1229-2024 — VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)Class II·Ongoing·Ortho-Clinical Diagnostics, Inc.·20240126
• Z-1220-2024 — VITROS 3600 Immunodiagnostic System (New and Refurbished)Class II·Ongoing·Ortho-Clinical Diagnostics, Inc.·20240122
• Z-0543-2024 — VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0Class II·Ongoing·Ortho-Clinical Diagnostics, Inc.·20231010
• Z-0008-2024 — Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)Class II·Ongoing·Ortho-Clinical Diagnostics, Inc.·20230809
• Z-2480-2020 — VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979Class II·Terminated·Ortho Clinical Diagnostics·20200520
• Z-2481-2020 — VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103Class II·Terminated·Ortho Clinical Diagnostics·20200520
• Z-2482-2020 — VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740Class II·Terminated·Ortho Clinical Diagnostics·20200520
• Z-2483-2020 — VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110Class II·Terminated·Ortho Clinical Diagnostics·20200520
• Z-2484-2020 — VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610Class II·Terminated·Ortho Clinical Diagnostics·20200520
• Z-1289-2019 — VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products ReagentsClass II·Terminated·Ortho-Clinical Diagnostics·20190220
• Z-1290-2019 — VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products ReagentsClass II·Terminated·Ortho-Clinical Diagnostics·20190220
• Z-0652-2019 — VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.Class II·Terminated·Ortho-Clinical Diagnostics·20181019
• Z-1322-2018 — VITROS Immunodiagnostic Products TSH Reagent PackClass III·Terminated·Clinical Diagnostic Systems·20180111
• Z-2580-2016 — VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.Class III·Terminated·ORTHO-CLINICAL DIAGNOSTICS·20160728
• Z-1913-2016 — VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.Class II·Terminated·Ortho-Clinical Diagnostics·20160406
• Z-0640-2016 — VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.Class II·Terminated·Ortho-Clinical Diagnostics·20151103
• Z-0967-2015 — VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.Class II·Terminated·Ortho-Clinical Diagnostics·20141119
• Z-0968-2015 — VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).Class II·Terminated·Ortho-Clinical Diagnostics·20141119

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083173.