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Ortho-Clinical Diagnostics, Inc. FDA Recalls
73 recalls on file across devices, 0 of them Class I and 65 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
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| Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total oClass IIJul 29, 2025VITROS Chemistry Products LAC Slides on VITROS XT 3400 and V |
| VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a Class IIJul 29, 2025VITROS Chemistry Products LAC Slides on VITROS XT 3400 and V |
| VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;Class IIJul 9, 2025Generations 67 and above of VITROS Ca Slides are experiencin |
| VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package cClass IIJun 12, 2025Lots from Generation (GEN) 15 of VITROS Chemistry Products O |
| VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);Class IIJun 10, 2025Quality control (QC) drift when certain lots of Performance |
| Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog NumClass IIJun 10, 2025Quality control (QC) drift when certain lots of Performance |
| VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);Class IIJun 10, 2025Quality control (QC) drift when certain lots of Performance |
| Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog NuClass IIJun 10, 2025Quality control (QC) drift when certain lots of Performance |
| Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 SoftwareClass IIMay 9, 2025a software anomaly allows test results to be reported using |
| Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; SClass IIMay 9, 2025a software anomaly allows test results to be reported using |
| Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915Class IIMay 9, 2025A software anomaly allows test results to be reported using |
| VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 9Class IIApr 14, 2025Product was incorrectly assigned GEN 88 instead of GEN 83 on |
| Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 SoftwareClass IIMar 24, 2025It was determined that there could be a false positive rate |
| Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (CertifiedClass IIDec 19, 2024The VITROS 5600 Integrated System software versions 3.8.0 ma |
| Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (CerClass IIDec 19, 2024The VITROS 3600 Immunodiagnostic System software versions 3. |
| Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (CertifClass IIDec 19, 2024The VITROS XT 7600 Integrated System software versions 3.8.0 |
| VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentrationClass IIOct 11, 2024May Generate Negatively Biased Results When Testing Samples |
| The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total proteinClass IIJul 10, 2024The reason for this recall is QuidelOrtho has determined tha |
| VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2Class IIJul 3, 2024It was confirmed that fibrinogen in patient plasma samples p |
| VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry ProduClass IIMay 21, 2024VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may |
| VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and theClass IIIMay 14, 2024Kit assigned an extended expiration date of 24-Jul-2025 duri |
| VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibClass IIIMay 8, 2024The results generated by the VITROS Immunodiagnostic Product |
| VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled CalibraClass IIMar 1, 2024Potential for positively biased results due to signal reduct |
| VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)Class IIJan 26, 2024A software defect affecting VITROS Systems running VITROS So |
| VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)Class IIJan 26, 2024A software defect affecting VITROS Systems running VITROS So |
| VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)Class IIJan 26, 2024A software defect affecting VITROS Systems running VITROS So |
| VITROS XT 7600 Integrated System, Catalog No. 6844461Class IIJan 26, 2024A software defect affecting VITROS Systems running VITROS So |
| VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)Class IIJan 26, 2024A software defect affecting VITROS Systems running VITROS So |
| VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)Class IIJan 26, 2024A software defect affecting VITROS Systems running VITROS So |
| VITROS XT 3400 Chemistry System, Catalog No. 6844458Class IIJan 26, 2024A software defect affecting VITROS Systems running VITROS So |
| VITROS XT 3400 Chemistry System, Catalog No. 6844458Class IIJan 26, 2024A software defect affecting VITROS Systems running VITROS So |
| VITROS XT 7600 Integrated System, Catalog No. 6844461Class IIJan 26, 2024A software defect affecting VITROS Systems running VITROS So |
| VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)Class IIJan 26, 2024A software defect affecting VITROS Systems running VITROS So |
| VITROS 5600 Integrated System (New and Refurbished)Class IIJan 22, 2024Potential For Aspiration from Unintended Sample Container Du |
| VITROS XT7600 Integrated SystemClass IIJan 22, 2024Potential For Aspiration from Unintended Sample Container Du |
| VITROS 3600 Immunodiagnostic System (New and Refurbished)Class IIJan 22, 2024Potential For Aspiration from Unintended Sample Container Du |
| VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic ProdClass IINov 27, 2023Affected lots may experience increased calibration failures |
| QMS Tacrolimus Calibrators, Product code 10015573Class IINov 21, 2023Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus |
| VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatClass IIOct 25, 2023Ortho Clinical Diagnostics (QuidelOrtho) confirmed during ro |
| VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3Class IIOct 10, 2023During planned monitoring of data post-release of Software V |
| VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0Class IIOct 10, 2023During planned monitoring of data post-release of Software V |
| VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0Class IIOct 10, 2023During planned monitoring of data post-release of Software V |
| VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0Class IIOct 10, 2023During planned monitoring of data post-release of Software V |
| VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0Class IIOct 10, 2023During planned monitoring of data post-release of Software V |
| VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains Class IISep 12, 2023Products 1668409 and 8297749 may contain VITROS Lipase Slide |
| Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 CheClass IIAug 9, 2023Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain P |
| VITROS XT Chemistry Products TBIL-ALKP SlidesClass IIAug 5, 2023Samples containing high levels of ALKP (or an interfering su |
| VITROS XT Chemistry Products ALKP SlidesClass IIAug 5, 2023Samples containing high levels of ALKP (or an interfering su |
| VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying theClass IIIMay 18, 2023May not meet the stability specifications for shelf life out |
| VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (Class IIApr 17, 2023Potential for both unexpected positive and negative HbA1c re |
| VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for DatClass IIApr 14, 2023Unavailable to calibrate VITROS Chemistry Products VANC Reag |
| VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement Class IIMar 10, 2023MicroTip Pack Opener Assembly Potentially Not Removing or Re |
| VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative Class IIMar 10, 2023MicroTip Pack Opener Assembly Potentially Not Removing or Re |
| VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of aClass IIMar 10, 2023MicroTip Pack Opener Assembly Potentially Not Removing or Re |
| VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADDClass IIMar 9, 2023Incorrect Number of Calibrator Levels (2) Set for the VITROS |
| VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hoClass IINov 17, 2022Lower than expected iPTH patient and Quality Control (QC) re |
| VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product CClass IIOct 13, 2022Calibration disk Data Release Version (DRV) 6194 to 6200 con |
| VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461Class IIJul 19, 2022Performing a system shutdown on VITROS XT 3400 and VITROS XT |
| VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458Class IIJul 19, 2022Performing a system shutdown on VITROS XT 3400 and VITROS XT |
| Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VClass IIMay 26, 2022On-Analyzer Stability (OAS) time, supported for 6 weeks; not |
| VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793Class IIMar 25, 2022Falsely high or delayed patient and QC results may occur due |
| VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922Class IIMar 25, 2022Falsely high or delayed patient and QC results may occur due |
| VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198Class IIMar 25, 2022Falsely high or delayed patient and QC results may occur due |
| VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.Class IIDec 10, 2021The lot has a shape deformity which may lead to a 16% reduct |
| VITROS Immunodiagnostic Products High Sample Diluent A Reagent PackClass IINov 22, 2021Lower than expected results for VITROS¿ Immunodiagnostic Pro |
| VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of tClass IIIOct 15, 2021Ortho Clinical Diagnostics confirmed a complaint that some V |
| VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performanceClass IISep 10, 2021VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantit |
| VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the quClass IIMay 3, 2021Ortho investigated and confirmed the potential for unexpecte |
| VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the Class IIMar 26, 2021Delayed results. Ortho confirmed that two lots of VITROS Bla |
| VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4Class IIFeb 18, 2021Potential total iron-binding capacity (TIBC) results. The V |
| VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products SClass IIFeb 12, 2021VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Re |
| VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used Class IIFeb 12, 2021VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Re |
| VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and reagenClass IIJan 14, 2021A deformity affecting a specific lot of VITROS¿ Chemistry Pr |