ORTHO-CLINICAL DIAGNOSTICS INC

VITROS 3600 · Hematology

510(k): 0 Recall: 7 UDI: 0 MAUDE: 9 Class.: 56

Recalls (7)

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:

2024-12-19

The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.

VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)

2024-01-26

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)

2024-01-26

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance …

VITROS 3600 Immunodiagnostic System (New and Refurbished)

2024-01-22

Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems which may lead to erroneous test results.

VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0

2023-10-10

During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system.…

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 6802

2023-08-09

Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Date code: 121922) may not perform as intended due to an out-of-specification barrel component. This may cause VITROS VersaTips and/or VITROS MicroTips to be improperly seated on the proboscis, which may result in falsely elevated Gentamicin a…

Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma

2018-11-29

A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.

MAUDE Adverse Events (9)

Malfunction

20260519

Malfunction

20260105

Malfunction

20250915

Malfunction

20250414

Malfunction

20250129

Malfunction

20250103

Malfunction

20240214

Injury

20240116

Malfunction

20230320

FDA Classification (56)

Assay, Heparin

Hematology

Adamts13 Activity Test System

Hematology

Stain, Papanicolau

Hematology

Tablet, Resazurin

Hematology

Solution, Silver Carbonate

Hematology

Ethyl Eosin

Hematology

Lymphocyte Separation Medium

Hematology

Microscope, Automated, Image Analysis, Operator Intervention

Hematology

Test, Sickle Cell

Hematology

Nigrosin

Hematology

Control, Platelet

Hematology

Oxyhemoglobin

Hematology

Plasma, Coagulation Control

Hematology

Indigocarmine

Hematology

Antithrombin Iii Quantitation

Hematology

Dna-Probe, B And T Lymphocyte

Hematology

Stains, Chemical Solution

Hematology

Neutral Red

Hematology

Reagent, Schiff

Hematology

Reagent, Russel Viper Venom

Hematology

Romanowsky Stains

Hematology

Centrifuge, Microsedimentation

Hematology

Giemsa Stain

Hematology

Adenine Nucleotide Quantitation

Hematology

Stains, Microbiologic

Hematology

Separator, Automated, Blood Cell, Diagnostic

Hematology

Centrifuge, Cell-Washing, Automated For Immuno-Hematology

Hematology

Analyzer, Chromosome, Automated

Hematology

Immunohistochemistry Reagents And Kits

Hematology

Products, Red-Cell Lysing Products

Hematology

Carbol Fuchsin

Hematology

Counter, Differential Cell

Hematology

Control Material, Blood Circulating Epithelial Cancer Cell

Hematology

Hemoglobinometer

Hematology

Crystal Violet For Histology

Hematology

Warmer, Blood, Non-Electromagnetic Radiation

Hematology

System, Automated Platelet Aggregation

Hematology

Whole Blood Hemoglobin Determination

Hematology

Jenner Stain

Hematology

Red-Cell Count By Photometry

Hematology

Stains, Heinz Body

Hematology

Fluid, Diluting, Red-Cell

Hematology

Reagent, Thromboplastin And Control

Hematology

Hematoxylin, Chrome Alum

Hematology

Reagent & Control, Partial Thromboplastin Time

Hematology

Hemoglobin For Donor Testing

Hematology

Carmine

Hematology

Bothrops Atrox Reagent

Hematology

Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

Hematology

Auramine O

Hematology

Assay, Glycosylated Hemoglobin

Hematology

Mucicarmine

Hematology

Control, Hemoglobin

Hematology

Red-Cell Indices, Measured

Hematology

Blood Establishment Computer Software And Accessories

Hematology

Van Gieson'S Picro-Fuchsin

Hematology