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Ortho-Clinical Diagnostics Recalls
311 recalls on record · August 1, 2012 to September 24, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 11, 2023Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid ho
Hazard: Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results
November 16, 2022Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product C
Hazard: Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lots of slide generation 22 (GEN 22). The erroneous mathematics on the calibration disk prevents the VITROS 250/350 Chemistry System from successfully calibrating, leading to delayed results.
September 14, 2022Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Hazard: Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
September 14, 2022Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
Hazard: Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
July 20, 2022Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and V
Hazard: On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
May 25, 2022Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc recalls VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
Hazard: Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.
May 25, 2022Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc recalls VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
Hazard: Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.
May 25, 2022Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc recalls VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Hazard: Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.
March 16, 2022Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
Hazard: The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.
January 26, 2022Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Hazard: Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.
November 24, 2021Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of t
Hazard: Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of patient test results is not affected by this issue, there is a potential for delayed results due to the troubleshooting of Quality Control results.
October 27, 2021Medical DevicesFDA
Ortho Clinical Diagnostics Inc recalls VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance
Hazard: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results
June 2, 2021Medical DevicesFDA
Ortho-Clinical Diagnostics, INc. recalls VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qu
Hazard: Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack along with VITROS Immunodiagnostic Products SARS-CoV-2 Ag Calibrator, Lot 20.
May 5, 2021Medical DevicesFDA
Ortho-Clinical Diagnostics, INc. recalls VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the
Hazard: Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly labelled as White Reference Slides. If the customer fails to notice both the product name or the unexpected color of the slides and tries to use Black Reference Slides as White Reference Slides, the Correction Factor test will fail - and the analyzer will not be able to produce results for any assays other than sodium, potassium, and chloride. If the customer doesnt have any White Reference Slides in reserve, they cant run the Correction Factor test correctly and get the analyzer running again until they get more White Reference Slides delivered. This could lead to a delay in results for all Vitros assays except for sodium, potassium, and chloride.
March 31, 2021Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4
Hazard: Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will start with the newest Generation (GEN) of VITROS Fe Slides (GEN 26), the potential shift in TIBC patient values of GEN 26 and above will be approximately 80 ug/dL lower across the measuring range than other available GENS of VITROS Fe Slides (GENs 22-25).
March 24, 2021Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used
Hazard: VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media
March 24, 2021Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products S
Hazard: VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media
March 3, 2021Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and reagen
Hazard: A deformity affecting a specific lot of VITROS¿ Chemistry Products VersaTips. Deformed VersaTips results may be biased by up to +/-16% for both immunometric and competitive assays.
January 20, 2021Medical DevicesFDA
Ortho Clinical Diagnostics Inc recalls VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concen
Hazard: Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
January 20, 2021Medical DevicesFDA
Ortho Clinical Diagnostics Inc recalls VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/3
Hazard: Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
January 13, 2021Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical
Hazard: A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample and potentially lead to inappropriate intervention with the potential for injury to the patient.
January 13, 2021Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the i
Hazard: A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample and potentially lead to inappropriate intervention with the potential for injury to the patient.
January 13, 2021Medical DevicesFDA
Ortho Clinical Diagnostics Inc recalls VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS
Hazard: VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference
November 25, 2020Medical DevicesFDA
Ortho Clinical Diagnostics Inc recalls VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance
Hazard: Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures
November 25, 2020Medical DevicesFDA
Ortho Clinical Diagnostics Inc recalls VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of
Hazard: Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control
November 25, 2020Medical DevicesFDA
Ortho Clinical Diagnostics Inc recalls VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identify
Hazard: Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control
September 2, 2020Medical DevicesFDA
Ortho Clinical Diagnostics recalls VITROS XT7600 Integrated System, Product code 6844461
Hazard: When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.
September 2, 2020Medical DevicesFDA
Ortho Clinical Diagnostics recalls VITROS XT3400 Chemistry System, Product code 6844458
Hazard: When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.
September 2, 2020Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within
Hazard: Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
September 2, 2020Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitative
Hazard: Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides