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.

126–150 of 221

  • HighFDA (Devices)·Z-1521-2015·2015-05-06

    Ortho-Clinical VITROS 5,1 FS Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems with software version 2.8 or below due to a potential anomaly that may cause the device to process samples with the wrong cartridge, leading to erroneous patient results.

    Product
    Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Global Trade Item Number 10758750001644; IVD. Intended for use in the in vi
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1263-2015·2015-03-18

    Ortho-Clinical VITROS Hand-held Barcode Scanner Recall for Sample Skipping

    Ortho-Clinical Diagnostics is recalling VITROS Hand-held Barcode Scanners because they may skip sample cup positions when using the Batch Programming option.

    Product
    VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS Chemistry System, VITROS 3600 Immunodiagnostics System, VITROS 4600 Chemistry System, VITROS 5600 Integrated System. This product is an accessory for use with VITRO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1004-2015·2015-01-28

    Ortho-Clinical VITROS Software Recall Due to Calibration Failure

    Ortho-Clinical Diagnostics is recalling VITROS Software Version 3.1 because calibration may not occur when using specific calibrator barcode labels.

    Product
    VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 - in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 - in vitro quantitative, semi-qua
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0968-2015·2015-01-21

    Ortho VITROS 4600 Chemistry System Recalled for Software Calibration Error

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because software versions 3.1 and below may fail to identify expired calibrations.

    Product
    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 bot
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0967-2015·2015-01-21

    Ortho VITROS 3600 Immunodiagnostic System Recalled for Software Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 3600 systems because software versions 3.1 and below may fail to identify expired calibrations.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0969-2015·2015-01-21

    Ortho VITROS 5600 System Recalled for Software Calibration Error

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because software may fail to identify expired calibrations.

    Product
    VITROS 5600 Integrated System, Catalog Number 6802413, 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 Chemistry Products Slides, VITROS Chemist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0848-2015·2014-12-31

    Ortho-Clinical Diagnostics Recalls VITROS TRIG Slides Due to Biased Results

    Ortho-Clinical Diagnostics is recalling specific VITROS TRIG slides due to a potential for biased test results. The recall affects 380 units in the US and 155 units internationally.

    Product
    VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0077-2015·2014-10-22

    Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems Due to Software Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because a software anomaly may cause unexpected assay calibration when using specific calibrator barcode labels.

    Product
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. 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 Sli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0078-2015·2014-10-22

    Ortho VITROS 5600 Integrated System Recalled for Calibration Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a software anomaly that may cause unexpected assay calibration when using specific calibrator kits.

    Product
    VITROS 5600 Integrated System, System Product Code 6802413. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0007-2015·2014-10-08

    Ortho-Clinical Diagnostics Recalls VITROS Phenytoin Slides Due to Potential Bias

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT Slides because they may produce biased results, potentially affecting patient care.

    Product
    VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2671-2014·2014-10-01

    Ortho-Clinical Diagnostics Recalls VITROS Anti-HCV Reagent Packs

    Ortho-Clinical Diagnostics is recalling VITROS Anti-HCV Reagent Packs due to signal loss that may cause false negative test results for hepatitis C.

    Product
    VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF 680 2454, IVD -- Ortho-Clinical Diagnostics High Wycombe UK. Note that one sales unit has 5 Reagen
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2183-2014·2014-08-20

    Ortho-Clinical Diagnostics Recalls VITROS CA 19-9 Reagent Packs and Calibrators

    Ortho-Clinical Diagnostics is recalling VITROS CA 19-9 Reagent Packs and Calibrators, Lot 1320, because they may produce positively biased results on specific VITROS systems.

    Product
    VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS¿ CA 19-9 Reagent Packs are used on VITROS¿ ECi/ECiQ Immunodiagnostic Systems, VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600 Integrated Systems for the quantitative measurement of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2214-2014·2014-08-20

    Ortho-Clinical VITROS Chemistry Calibration Modules Recalled for Calibration Failure

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CDM PROM Calibration Data Modules because they prevent the calibration and use of specific ammonia test slides.

    Product
    VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS¿ Chemistry Products DT Calibrator Kit lot 44 (Product Code 1957
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2140-2014·2014-08-13

    Ortho VITROS 4600 Chemistry System Recalled for Software Error

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because a software anomaly may associate incorrect patient demographics with sample IDs.

    Product
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- 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, r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2139-2014·2014-08-13

    Ortho VITROS 3600 Immunodiagnostic System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 3600 systems due to a software defect that may associate incorrect patient demographics with sample IDs.

    Product
    VITROS 3600 Immunodiagnostic System --- 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. The VITROS Software is a part of the VITROS 3600, 4600, & 5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2141-2014·2014-08-13

    Ortho-Clinical Diagnostics Recalls VITROS 5600 Systems Due to Software Error

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because a software anomaly may associate incorrect patient demographics with sample IDs.

    Product
    VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1804-2014·2014-06-25

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products Calibrator Kit 17

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 17 because calibrator values were assigned using a reference method that was not fully validated.

    Product
    VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Sys
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1805-2014·2014-06-25

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products FS Calibrator 1

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products FS Calibrator 1 because calibrator values were assigned using a reference method that was not fully validated.

    Product
    VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- For in vitro diagnostic use only --- VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600 Chem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1734-2014·2014-06-18

    Ortho-Clinical VITROS 4600 Chemistry System Recalled for Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems due to a potential for biased results when using Multiple Window codes.

    Product
    VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1735-2014·2014-06-18

    Ortho-Clinical VITROS 5600 Integrated System Recalled for Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a software issue that may cause biased results when using Multiple Window codes.

    Product
    VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1738-2014·2014-06-18

    Ortho-Clinical enGen Laboratory Automation Systems Recalled for Software Anomaly

    Ortho-Clinical Diagnostics is recalling enGen Laboratory Automation Systems with specific TCAutomation software versions due to a potential delay in reporting patient sample test results.

    Product
    enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clinical interest; for pre-analytical and post-analytical sample and data management. --- Background: The enGen Lab Automation System is a modifica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1736-2014·2014-06-18

    Ortho-Clinical VITROS 5,1 FS Chemistry System Recalled for Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a potential for biased results when specific Multiple Window codes are used.

    Product
    VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1741-2014·2014-06-18

    Ortho-Clinical enGen Laboratory Automation System Software Recall

    Ortho-Clinical Diagnostics is recalling enGen Laboratory Automation Systems configured with TCAutomation Software v3.5 due to potential buffer timeout issues.

    Product
    enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety of analytes of clinical interest --- The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in th
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1677-2014·2014-06-11

    Ortho-Clinical enGen Laboratory Automation System Software Recall

    Ortho-Clinical Diagnostics is recalling the enGen Laboratory Automation System due to a software anomaly that may delay patient test results.

    Product
    enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest --- Background: The enGen (TM) Lab Automation System is a modification to VI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1648-2014·2014-05-28

    Ortho-Clinical VITROS TT4 Calibrator Recalled for Calibration Failures

    Ortho-Clinical Diagnostics is recalling VITROS TT4 Calibrators due to potential calibration failures or low quality control results.

    Product
    VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) 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 differenti
    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.