VITROSRecalls & reported problems across all models

We found 71 models of VITROS by Ortho-Clinical Diagnostics, Inc. in the FDA's device registry (GUDID). Together they are named in 806 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2022 and Sep 30, 2026 — classified as 5 injuries, 801 malfunctions.

The most frequently reported specific device problem is “High Test Results” (483 reports).

96 FDA recall records name at least one of these models by its device identifier, 61 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

VITROS recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 29, 2025Open, Classified

   VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024.

   Z-2560-2025 · Root cause: Device Design · Recall details · FDA record ↗

2. Jul 9, 2025Open, Classified

   Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive "spikes" (imperfections) in slide images and generates the TH4-63J condition code when the threshold of 600 spikes is exceeded. Updated analysis revealed a 19-fold increase in failure rates from 0.0043% (2024 baseline) to 0.082% for Generation 67+ slides in 2025, with 100% of calibrator failures occurring at the lowest concentration level. This can result in delayed diagnosis and treatment of conditions such as hypercalcemic crisis, parathyroid disorders, and other calcium-related emergencies requiring urgent intervention.

   Z-2335-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Jun 12, 2025Open, Classified

   Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results.

   Z-2073-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Jun 10, 2025Open, Classified

   Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).

   Z-2122-2025 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

5. Jun 10, 2025Open, Classified

   Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).

   Z-2121-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. Jun 10, 2025Open, Classified

   Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).

   Z-2120-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

7. May 9, 2025Open, Classified

   a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.

   Z-2040-2025 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗

8. May 9, 2025Open, Classified

   a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.

   Z-2039-2025 · Root cause: Software design · Recall details · FDA record ↗

9. May 9, 2025Open, Classified

   A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.

   Z-2038-2025 · Root cause: Software design · Recall details · FDA record ↗

10. Apr 24, 2025Open, Classified

    transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

    Z-1837-2025 · Root cause: Storage · Recall details · FDA record ↗

11. Apr 24, 2025Open, Classified

    transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

    Z-1835-2025 · Root cause: Storage · Recall details · FDA record ↗

12. Apr 24, 2025Open, Classified

    transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

    Z-1834-2025 · Root cause: Storage · Recall details · FDA record ↗

13. Apr 24, 2025Open, Classified

    transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

    Z-1833-2025 · Root cause: Storage · Recall details · FDA record ↗

14. Apr 24, 2025Open, Classified

    transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

    Z-1832-2025 · Root cause: Storage · Recall details · FDA record ↗

15. Apr 24, 2025Open, Classified

    transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

    Z-1831-2025 · Root cause: Storage · Recall details · FDA record ↗

16. Apr 14, 2025Open, Classified

    Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.

    Z-1876-2025 · Root cause: Process control · Recall details · FDA record ↗

17. Dec 19, 2024Open, Classified

    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.

    Z-1007-2025 · Root cause: Software Design Change · Recall details · FDA record ↗

18. Dec 19, 2024Open, Classified

    The VITROS XT 7600 Integrated 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.

    Z-1006-2025 · Root cause: Software Design Change · Recall details · FDA record ↗

19. Dec 19, 2024Open, Classified

    The VITROS 5600 Integrated 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.

    Z-1005-2025 · Root cause: Software Design Change · Recall details · FDA record ↗

20. Dec 5, 2024Open, Classified

    Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.

    Z-0902-2025 · Root cause: Device Design · Recall details · FDA record ↗

21. Dec 5, 2024Open, Classified

    Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.

    Z-0901-2025 · Root cause: Device Design · Recall details · FDA record ↗

22. Oct 11, 2024Open, Classified

    May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to know if the sample has to be diluted to measure again.

    Z-0535-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

23. Jul 10, 2024Open, Classified

    The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB-TP Slides may shed dust and debris as they travel through the MicroSlide Subsystem of the VITROS XT 3400 or VITROS XT 7600 analyzer. This dust and debris may then settle onto VITROS Na+ (Sodium) Slides as they are processed through the same MicroSlide Subsystem, potentially resulting in an increase in non-reproducible, positively, or negatively biased Na+ results. The level of bias will depend on where the dust and debris settle on the Na+ MicroSlide and may impact Na+ measurements to varying degrees inside and outside of the measuring range depending on the amount of contamination. All of which could vary from no/low bias with no patient harm, to extreme bias (falsely elevated or reduced results) potentially resulting in incorrect diagnosis; treatment; and/or a serious patient health hazard (for example, hypernatremia or hyponatremia). This issue may also potentially generate error codes preventing the analyzer from processing the MicroSlide Assays and cause delay of the patient results. All current and expired VITROS XT Chemistry Products ALB-TP slides are affected by this issue.

    Z-2684-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

24. May 21, 2024Open, Classified

    VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.

    Z-2266-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

25. May 14, 2024Open, Classified

    Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration date for Lot 2953 is 24-Jul-2024. If used past its true expiration and the customer does not have their Assay Data Disk (ADD) updated, the system will allow them to use the expired calibrator which may bias the results. However, at this time the calibrator is within its use date and will function appropriately.

    Z-2245-2024 · Root cause: Labeling design · Recall details · FDA record ↗

26. Feb 27, 2024Open, Classified

    The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.

    Z-1373-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

27. Feb 27, 2024Open, Classified

    The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.

    Z-1372-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

28. Jan 26, 2024Open, Classified

    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 criteria, which may cause erroneous patient results to be reported.

    Z-1233-2024 · Root cause: Software Design Change · Recall details · FDA record ↗

29. Jan 26, 2024Open, Classified

    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 criteria, which may cause erroneous patient results to be reported.

    Z-1232-2024 · Root cause: Software Design Change · Recall details · FDA record ↗

30. Jan 26, 2024Open, Classified

    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 criteria, which may cause erroneous patient results to be reported.

    Z-1231-2024 · Root cause: Software Design Change · names 2 of these models · Recall details · FDA record ↗

…and 66 older recalls, listed on each model's page.

Most reported VITROS problems

VITROS models

71 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VITROS 6802413

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  12 recalls69 reports
• VITROS 6802445

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  9 recalls18 reports
• VITROS 6802783

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  8 recalls8 reports
• VITROS 6802915

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  8 recalls3 reports
• VITROS 6844461

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  6 recalls92 reports
• VITROS 6802914

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  6 recalls0 reports
• VITROS 6900440

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  5 recalls0 reports
• VITROS 6844458

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  4 recalls2 reports
• VITROS 6844296

  NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES
  4 recalls0 reports
• VITROS 8231474

  Calibrator, secondary
  3 recalls0 reports
• VITROS 8343386

  ENZYME IMMUNOASSAY, DIGITOXIN
  2 recalls46 reports
• VITROS 8379034

  ELECTRODE, ION SPECIFIC, SODIUM
  1 recall76 reports
• VITROS 8298671

  ENZYME IMMUNOASSAY, DIPHENYLHYDANTOIN
  1 recall67 reports
• VITROS 1450261

  AZO DYE, CALCIUM
  2 recalls7 reports
• VITROS 6844508

  Calibrator, multi-analyte mixture
  2 recalls7 reports
• VITROS 6199949

  Coronavirus antigen detection test system.
  2 recalls1 report
• VITROS 8067324

  Calibrator, secondary
  2 recalls0 reports
• VITROS 6801754

  General purpose reagent
  2 recalls0 reports
• VITROS 6844293

  BROMCRESOL GREEN DYE-BINDING, ALBUMIN
  2 recalls0 reports
• VITROS 1707801

  GLUCOSE OXIDASE, GLUCOSE
  1 recall48 reports
• VITROS 6801709

  RADIOIMMUNOASSAY, VANCOMYCIN
  1 recall23 reports
• VITROS 6801710

  ENZYME IMMUNOASSAY, VALPROIC ACID
  1 recall23 reports
• VITROS 6842905

  Hemoglobin A1c test system
  1 recall21 reports
• VITROS 6802153

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  1 recall18 reports
• VITROS 8568040

  CALIBRATOR, SECONDARY
  1 recall18 reports
• VITROS 1662659

  CALIBRATOR, MULTI-ANALYTE MIXTURE
  1 recall17 reports
• VITROS 1922814

  FLUOROMETER, FOR CLINICAL USE
  1 recall10 reports
• VITROS 8001133

  DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES
  1 recall10 reports
• VITROS 8058232

  DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES
  1 recall9 reports
• VITROS 8150112

  ACID, LACTIC, ENZYMATIC METHOD
  1 recall8 reports
• VITROS 8383051

  DIAZO COLORIMETRY, BILIRUBIN
  1 recall5 reports
• VITROS 6802584

  ENZYMATIC METHOD, CREATININE
  52 reports
• VITROS 6801059

  FLUOROMETER, FOR CLINICAL USE
  1 recall1 report
• VITROS 8097990

  C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL
  1 recall1 report
• VITROS 6801696

  CALIBRATORS, DRUG SPECIFIC
  1 recall1 report
• VITROS 1204668

  CALIBRATOR, SECONDARY
  1 recall1 report
• VITROS 1612365

  DIAZO COLORIMETRY, BILIRUBIN
  1 recall1 report
• VITROS 1914605

  Colorimetry, cholinesterase
  1 recall0 reports
• VITROS 1926740

  C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL
  1 recall0 reports
• VITROS 6801759

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  1 recall0 reports
• VITROS 6801997

  ENZYME IMMUNOASSAY, OPIATES
  1 recall0 reports
• VITROS 6802344

  CALIBRATOR, PRIMARY
  1 recall0 reports
• VITROS 8004707

  Colorimetry, cholinesterase
  1 recall0 reports
• VITROS 8102204

  UREASE, PHOTOMETRIC, UREA NITROGEN
  1 recall0 reports
• VITROS 8262396

  ENZYMATIC, CARBON-DIOXIDE
  1 recall0 reports
• VITROS 8297749

  LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE
  1 recall0 reports
• VITROS 8392292

  BIURET (COLORIMETRIC), TOTAL PROTEIN
  1 recall0 reports
• VITROS 6801704

  CALIBRATOR, SECONDARY
  1 recall0 reports
• VITROS 1053180

  NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES
  1 recall0 reports
• VITROS 1513209

  Phosphomolybdate (colorimetric), inorganic phosphorus
  1 recall0 reports
• VITROS 1668409

  LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE
  1 recall0 reports
• VITROS 6199950

  Coronavirus antigen detection test system.
  1 recall0 reports
• VITROS 6199976

  Reagent, coronavirus serological
  1 recall0 reports
• VITROS 1726926

  PHOTOMETRIC METHOD, AMMONIA
  29 reports
• VITROS 8157596

  ELECTRODE, ION SPECIFIC, POTASSIUM
  26 reports
• VITROS 1882208

  CALIBRATOR, MULTI-ANALYTE MIXTURE
  23 reports
• VITROS 1721869

  PHOTOMETRIC METHOD, AMMONIA
  17 reports
• VITROS 8221384

  ENZYME IMMUNOASSAY, PHENOBARBITAL
  9 reports
• VITROS 6844295

  GLUCOSE OXIDASE, GLUCOSE
  8 reports
• VITROS 8892382

  ENZYME IMMUNOASSAY, CARBAMAZEPINE
  6 reports
• VITROS 6844294

  UREASE, PHOTOMETRIC, UREA NITROGEN
  5 reports
• VITROS 1632660

  FLAME PHOTOMETRY, LITHIUM
  4 reports
• VITROS 6801989

  Enzyme immunoassay, benzodiazepine
  3 reports
• VITROS 6801697

  CALIBRATORS, DRUG SPECIFIC
  3 reports
• VITROS 1149764

  BROMCRESOL GREEN DYE-BINDING, ALBUMIN
  3 reports
• VITROS 6802413B

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  2 reports
• VITROS 8262487

  General purpose reagent
  1 report
• VITROS 8433880

  ACID, LACTIC, ENZYMATIC METHOD
  1 report
• VITROS 6801732

  METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)
  1 report
• VITROS 1037274

  COLORIMETRY, ACETAMINOPHEN
  1 report
• VITROS 1204247

  DIAZO COLORIMETRY, BILIRUBIN
  1 report

Recent VITROS adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Low Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951324 ↗
• MalfunctionSep 29, 2026High Test Results

  A customer contacted the Ortho Clinical Diagnostics (Ortho) Technical Solution Center (TSC) to report higher than expected HbA1c results were obtained from a non-VITROS BioRad quality control processed using VITROS Chemistry Products HbA1c Reagent Lot 2539-51-3990 on a VITROS XT 7600 Integrated System. BioRad Lot 89280 Level 2 results of 10.2, 10.4, 10.4 and 10.5 %A1c vs an expected result of 8.6 %A1c Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The higher than expected results were obtained from a control fluid and were not reported out of the laboratory. There has been no allegation of patient harm as a result of this event. This report is number one of two MDRs for this event. Two 3500a forms are being submitted for this event as two devices were involved. This report corresponds to Ortho Clinical Diagnostics Inc (Ortho) complaint number 101168810 and Reportability Assessment 615838.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937674 ↗
• MalfunctionSep 29, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937661 ↗
• MalfunctionSep 25, 2026High Test Results; Non Reproducible Results

  An Ortho Field Application Specialist (FAS) on behalf of a customer, contacted the Ortho Clinical Diagnostics (Ortho) Global Technical Solutions Center (TSC) to report a non-reproducible, higher than expected VITROS AMON result was obtained from a single patient sample processed using VITROS Chemistry Products AMON Slides Lot 1022-0269-7519 on a VITROS XT 3400 Chemistry System. Patient sample VITROS AMON result of 261.1 umol/L versus an expected result of 114.7 umol/L Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected. The non-reproducible, higher than expected VITROS AMON result was not reported out of the laboratory. There have been no allegations of patient harm as a result of this event. This report corresponds to Ortho Clinical Diagnostics Inc (Ortho) complaint number (b)(4) and Reportability Assessment 615879.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899006 ↗
• InjurySep 24, 2026Use of Device Problem

  A customer contacted the Ortho Clinical Diagnostics (Ortho) Technical Solution Center (TSC) to report that the operator sustained a thumb laceration during separate events involving the removal of metal seals from various VITROS Calibrator bottles. The operator did not seek medical attention or treatment for any of the injuries. No long-term serious injury was sustained. The operator did not seek medical treatment for the lacerations. The injury did not require any medical attention. There was no allegation of a serious or long-term permanent injury. This report corresponds to Ortho Clinical Diagnostics Inc (Ortho) complaint number (b)(4) and Reportability Assessment (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882098 ↗
• MalfunctionSep 23, 2026High Test Results; Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872030 ↗
• MalfunctionSep 22, 2026High Test Results; Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858751 ↗
• MalfunctionSep 22, 2026High Test Results; Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858728 ↗
• MalfunctionSep 22, 2026High Test Results; Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858718 ↗
• MalfunctionSep 22, 2026High Test Results; Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858701 ↗
• MalfunctionSep 22, 2026High Test Results; Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858648 ↗
• MalfunctionSep 22, 2026High Test Results; Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858628 ↗
• MalfunctionSep 22, 2026High Test Results; Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858571 ↗
• MalfunctionSep 18, 2026High Test Results; Non Reproducible Results

  A customer contacted the Ortho Clinical Diagnostics (Ortho) Technical Solution Center (TSC) to report a non-reproducible, higher than expected VITROS Creatinine (CREA) result was obtained from a single patient sample tested using VITROS CREA slide lot 1520-3584-1928 on a VITROS XT3400 Chemistry System. Patient sample VITROS CREA result of 172 umol/L vs. the expected result of 76 umol/L Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected. The higher than expected VITROS CREA result was reported outside of the laboratory. No corrected report was issued at this time. However, it was confirmed that no treatment was stopped/ started or altered based on the higher than expected result. There was no allegation of patient harm as a result of the event. This report corresponds to Ortho Clinical Diagnostics Inc (Ortho) complaint number (b)(4) and Reportability Assessment 615780.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817035 ↗
• MalfunctionSep 11, 2026Low Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736852 ↗

Other Ortho-Clinical Diagnostics, Inc. products

• BIOCLONE3 models · 8 reports · 1 recall
• RESOLVE3 models · 38 reports
• SURGISCREEN2 models · 30 reports