The Recall Desk

Manufacturer

Ortho Clinical Diagnostics

221 recalls in our database name Ortho Clinical Diagnostics as the manufacturing or recalling firm.

What the numbers show

Total
221
Critical
0
Severe
10
Most recent
2024-04-03

Of the 221 recalls from Ortho Clinical Diagnostics we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (5%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 221

  • HighFDA (Devices)·Z-1373-2024·2024-04-03

    Clinical Laboratory Quality Control Device Recalled for Diluent Assembly Error

    Ortho-Clinical Diagnostics is recalling 11,224 units of VITROS Performance Verifier II due to incorrect diluent assembly, which may produce inaccurate quality control results and potentially erroneous patient test results.

    Product
    VITROS Performance Verifier II
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1372-2024·2024-04-03

    Laboratory performance verifier recalled for mismatched diluent assembly

    Ortho-Clinical Diagnostics is recalling 10,911 units of VITROS Performance Verifier I worldwide due to mismatched diluent components that could cause inaccurate quality control test results.

    Product
    VITROS Performance Verifier I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2358-2023·2023-08-16

    FDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives

    Ortho-Clinical Diagnostics is recalling VITROS Troponin I ES Calibrators because reagent packs may contain incorrect wells that could produce false negative results. The recall affects 4,013 units distributed worldwide.

    Product
    VITROS Immunodiagnostic Products Troponin I ES Calibrators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2357-2023·2023-08-16

    VITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells

    ORTHO-CLINICAL DIAGNOSTICS is recalling VITROS Troponin I ES Reagent Pack due to potential incorrect wells that could generate false negative diagnostic results. Lot 4800 with expiration 10-Jun-2023 is affected.

    Product
    VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2129-2023·2023-07-19

    Ortho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Calibrator Kit 20 due to measurement bias affecting laboratory results for immunoglobulin and complement protein testing. Falsely elevated or reduced values could be reported.

    Product
    VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2879-2020·2020-09-02

    Ortho VITROS XT7600 System Recalled for Potential Mis-positioned Slides

    Ortho Clinical Diagnostics is recalling VITROS XT7600 Integrated Systems because slides in Slot 18 may be mis-positioned, leading to erroneous test results.

    Product
    VITROS XT7600 Integrated System, Product code 6844461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2873-2020·2020-09-02

    Ortho-Clinical Diagnostics Recalls VITROS TBIL Slides Due to Etrombopag Interference

    Ortho-Clinical Diagnostics is recalling VITROS TBIL Slides because the drug etrombopag can interfere with test results, potentially leading to inaccurate total bilirubin measurements.

    Product
    VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and plasma, Product code: 8159931
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2878-2020·2020-09-02

    Ortho VITROS XT3400 Chemistry System Recalled for Erroneous Results

    Ortho Clinical Diagnostics is recalling VITROS XT3400 Chemistry Systems because slides in Slot 18 may be mis-positioned, leading to erroneous test results.

    Product
    VITROS XT3400 Chemistry System, Product code 6844458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2874-2020·2020-09-02

    Ortho-Clinical VITROS Chemistry BuBc Slides Recalled for Etrombopag Interference

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products BuBc Slides because the drug etrombopag interferes with the test results.

    Product
    VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma, Product code: 8383051 (60 slide); 1612365 (18 slide)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2875-2020·2020-09-02

    Ortho-Clinical Diagnostics Recalls VITROS XT Chemistry TBIL-ALKP Slides

    Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry TBIL-ALKP Slides due to potential interference from etrombopag that may affect total bilirubin test results.

    Product
    VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2770-2020·2020-08-19

    Ortho VITROS Anti-SARS-CoV-2 Reagent Recalled for Potential False Negatives

    Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Total Reagent because swapped bottles may cause false negative or delayed results.

    Product
    VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2771-2020·2020-08-19

    Ortho Clinical Diagnostics Recalls VITROS Anti-SARS-CoV-2 IgG Reagent Packs

    Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 IgG Reagent Packs because swapped reagent bottles may cause false negative or delayed results.

    Product
    VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2481-2020·2020-07-08

    Ortho VITROS 3600 System Recalled for Assay Parameter Reset Issue

    Ortho Clinical Diagnostics is recalling 27 refurbished VITROS 3600 Immunodiagnostic Systems because assay parameters may reset to defaults, potentially affecting test results.

    Product
    VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2480-2020·2020-07-08

    Ortho VITROS 3600 Software Recall for Parameter Reset Issue

    Ortho Clinical Diagnostics is recalling VITROS 3600 Immunodiagnostic System software versions 3.3.3 and below because MicroWell Qualitative Assay parameters may reset to defaults.

    Product
    VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2482-2020·2020-07-08

    Ortho VITROS 5600 Software Recall for Parameter Reset Defect

    Ortho Clinical Diagnostics is recalling VITROS 5600 Integrated System software versions 3.3.3 and below because assay parameters may reset to defaults.

    Product
    VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2484-2020·2020-07-08

    Ortho VITROS XT 7600 Software Recall for Parameter Reset Issue

    Ortho Clinical Diagnostics is recalling VITROS XT 7600 Integrated System software versions 3.5.1 and below because MicroWell Qualitative Assay parameters may reset to defaults.

    Product
    VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2483-2020·2020-07-08

    Ortho VITROS 5600 System Recall for Software Parameter Reset Issue

    Ortho Clinical Diagnostics is recalling 130 refurbished VITROS 5600 Integrated Systems because software modifications to assay parameters may be inadvertently reset to default.

    Product
    VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2365-2020·2020-06-24

    Ortho-Clinical Diagnostics Recalls VITROS AMYL Slides Reagent for Imprecision

    Ortho-Clinical Diagnostics is recalling VITROS AMYL Slides Reagent because multiple coatings show imprecision on control fluids compared to expected standards.

    Product
    VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2364-2020·2020-06-24

    Ortho-Clinical Diagnostics Recalls VITROS AMYL Slides Reagent for Imprecision

    Ortho-Clinical Diagnostics is recalling VITROS AMYL Slides Reagent because multiple coatings show imprecision on control fluids. The product is used for in vitro diagnostic testing.

    Product
    VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2367-2020·2020-06-24

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Performance Verifier II

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Performance Verifier II units because multiple coatings of AMYL Slides show imprecision on control fluids.

    Product
    VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2366-2020·2020-06-24

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Performance Verifier I

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Performance Verifier I units because multiple coatings of AMYL Slides show imprecision on control fluids.

    Product
    VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1930-2020·2020-05-20

    Ortho-Clinical Diagnostics Recalls VITROS CKMB Slides Due to Incorrect Instructions

    Ortho-Clinical Diagnostics is recalling VITROS CKMB Slides because Spanish and Swedish instructions incorrectly state the assay can be tested with plasma, which could result in biased results.

    Product
    VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1931-2020·2020-05-20

    Ortho-Clinical Diagnostics Recalls VITROS CKMB Slides Due to Incorrect Instructions

    Ortho-Clinical Diagnostics is recalling VITROS CKMB Slides because Spanish and Swedish instructions incorrectly state the assay can be tested with plasma, which could result in biased results.

    Product
    VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1834-2020·2020-05-06

    Ortho VITROS TT4 Reagent Pack Recalled for Calibration Failures

    Ortho Clinical Diagnostics is recalling VITROS TT4 Reagent Packs due to increased unsuccessful calibrations. The recall affects 3,181 units distributed in the US and 23 other countries.

    Product
    VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0268-2020·2019-11-13

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Cl- Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS chemistry Cl- Slides because the anti-backup platen may fail to advance, causing intermittent slide dispense issues.

    Product
    VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Ortho-Clinical Diagnostics

in vitro diagnostics company for blood testing

Country
United States
Founded
1994

Official website

Source: Wikidata (Q7104389), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.