VITROS 6802783Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10758750002979), received between Apr 27, 2023 and Jun 3, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (3 reports).

8 FDA recall records name this device's identifier, 5 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 · FDA record ↗

2. Jan 26, 2024Open, Classified

   A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

   Z-1224-2024 · Root cause: Software Design Change · FDA record ↗

3. 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-1229-2024 · Root cause: Software Design Change · FDA record ↗

4. Jan 22, 2024Open, Classified

   Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems which may lead to erroneous test results.

   Z-1220-2024 · Root cause: Component change control · FDA record ↗

5. Oct 10, 2023Open, Classified

   During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.

   Z-0543-2024 · Root cause: Under Investigation by firm · FDA record ↗

6. Feb 20, 2019Terminated

   Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems

   Z-1289-2019 · Root cause: Software design · FDA record ↗

7. Oct 19, 2018Terminated

   Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.

   Z-0652-2019 · Root cause: Software Manufacturing/Software Deployment · FDA record ↗

8. Apr 6, 2016Terminated

   Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results.

   Z-1913-2016 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 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 TROPI ES RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. PATIENT SAMPLE 1 RESULT OF 0.057 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML 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 TROPI ES RESULT WAS NOT REPORTED FROM THE LABORATORY AND THERE HAS BEEN NO ALLEGATION 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25375885 ↗
• MalfunctionFeb 3, 2026High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPONIN I ES (TROPI ES) RESULTS WERE OBTAINED FROM SEVEN DIFFERENT PATIENT SAMPLES TESTED USING VITROS TROPI ES REAGENT LOT: 6210 TESTED ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. PATIENT 1 SAMPLE RESULT OF 0.276 NG/ML VS. THE EXPECTED RESULT OF <0.0123 NG/ML PATIENT 2 SAMPLE RESULT OF 0.718 NG/ML VS. THE EXPECTED RESULT OF <0.012 NG/ML PATIENT 3 SAMPLE RESULT OF 1.410 NG/ML VS. THE EXPECTED RESULT OF <0.0123 NG/ML PATIENT 4 SAMPLE RESULT OF 2.330 NG/ML VS. THE EXPECTED RESULT OF <0.012 NG/ML PATIENT 5 SAMPLE RESULT OF 1.570 NG/ML VS. THE EXPECTED RESULT OF <0.012 NG/ML PATIENT 6 SAMPLE RESULT OF 1.960 NG/ML VS. THE EXPECTED RESULT OF <0.012 NG/ML PATIENT 8 SAMPLE RESULT OF 0.173 NG/ML VS. THE EXPECTED RESULT OF 0.017 NG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED, NON-REPRODUCIBLE VITROS TROPI ES RESULT OBTAINED FROM ALL SEVEN SAMPLES WERE REPORTED OUTSIDE THE LABORATORY, HOWEVER, THE PHYSICIANS QUESTIONED THE RESULTS PRI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248774 ↗
• MalfunctionMay 9, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED B-HCG II RESULTS WERE OBTAINED FROM A LEVEL 3 NON-VITROS MAS OMNI IMMUNE QUALITY CONTROL (QC) FLUID LOT OIM2612 WHEN TESTED USING VITROS IMMUNODIAGNOSTICS PRODUCT B-HCG II REAGENT LOT 4350 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. MAS LOT OIM2612 LEVEL 3 QC FLUID RESULTS OF 71.374 AND 73.815 MIU/ML VS. THE EXPECTED RESULT OF 796.320 MIU/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER THAN EXPECTED VITROS B-HCG II RESULTS WERE FROM A NON-PATIENT FLUID AND WERE NOT REPORTED FROM THE LABORATORY. THE CUSTOMER DID NOT GIVE ANY INDICATION THAT PATIENT RESULTS HAD BEEN AFFECTED, AND ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993130 ↗
• MalfunctionFeb 25, 2025False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT FALSE NEGATIVE VITROS ANTI-HAV IGM (AHAVM) AND VITROS ANTI-HBC IGM (AHBCM) RESULTS WERE OBTAINED WHEN TESTED USING A NON-VITROS (BIORAD) VIROTROL III QUALITY CONTROL (QC) FLUID LOT 124480 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. VITROS AHAVM RESULTS OF 0.01 AND 0.01 S/C (NON-REACTIVE) VERSUS EXPECTED RESULTS OF 2.34 S/C (REACTIVE) VITROS AHBCM RESULTS OF 0.03, 0.03, 0.71, 0.76, 0.74, 0.77, 0.81, 0.85 AND 0.83 S/C (NON-REACTIVE) VERSUS EXPECTED RESULTS OF 1.44 S/C (REACTIVE) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE DISCORDANT FALSE NEGATIVE VITROS AHAVM AND AHBCM RESULTS WERE OBTAINED FROM A NON-PATIENT FLUID. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21461816 ↗
• MalfunctionFeb 3, 2025False Negative Result; Low Test Results; False Negative Result; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT FALSE NEGATIVE VITROS TOXO PLASMA IGM (TOXO M) RESULTS AND LOWER THAN EXPECTED VITROS TOTAL PSA II (TPSA II) RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING NON-VITROS BIORAD AND FUJIREBIO TUMOR MARKER QUALITY CONTROL FLUIDS, ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. VITROS TOXO M LOT 2360: BIORAD VIROTROL QC RESULTS OF NON-REACTIVE (0.527, 0.495 S/C) VERSUS EXPECTED RESULT OF REACTIVE VITROS TPSA II: FUJIREBIO QC LEVEL 1 RESULTS OF 0.485 (VITROS TPSA II LOT 1630) AND 1.703 (VITROS TPSA II LOT 1640) NG/ML VERSUS EXPECTED RESULT OF 3.21 NG/ML FUJIREBIO QC LEVEL 2 RESULTS OF 3.490, 3.750 (VITROS TPSA II LOT 1630) AND 15.38 (VITROS TPSA II LOT 1640) NG/ML VERSUS EXPECTED RESULT OF 28.2 NG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE DISCORDANT, FALSE NEGATIVE VITROS TOXO IGM RESULTS AND THE LOWER-THAN-EXPECTED VITROS TPSA II RESULTS WERE OBTAINED FROM NON-PATIENT FLUID. THE CUSTOMER DID NOT GIVE ANY INDICATION THAT PATIENT RESULTS HAD BEEN AFFECTED. ORTHO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293405 ↗
• MalfunctionMar 13, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED BIORAD AND VITROS QC RESULTS WERE OBTAINED FOLLOWING THE CALIBRATION OF VITROS TSH REAGENT LOT 7200 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. BIORAD LOT 40410, LEVEL 3 REUSLT OF 42.50 VERSUS THE EXPECTED RESULT OF 32.6 MIU/ML VITROS FREE THYROID CONTROL LOT 761, LEVEL 2 RESULT OF 1.712 VERSUS THE EXPECTED RESULT OF 1.31 MIU/ML VITROS FREE THYROID CONTROL LOT 761, LEVEL 3 RESULT OF 27.68 VERSUS THE EXPECTED RESULT OF 20.2 MIU/ML 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 VITROS TSH RESULTS WERE OBTAINED FROM NON-PATIENT FLUIDS. THERE WAS NO ALLEGATION 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896277 ↗
• InjuryFeb 16, 2024Leak/Splash; Leak/Splash

  A CUSTOMER REPORTED THAT WHEN THE OPERATOR OPENED THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM'S MICROWELL INCUBATOR THEY WERE SPLASHED IN THEIR EYES WITH FLUID FROM MICROWELLS STUCK TO THE INCUBATOR COVER. THE SPLASH HAPPENED WHEN THE WELLS STUCK TO THE COVER FELL BACK INTO THE INCUBATOR. THIS INCIDENCE IS CONSIDERED AS BLOOD BORNE PATHOGEN EXPOSURE TO THE MUCOSA. THE CUSTOMER WAS PERFORMING PATIENT SAMPLE TESTING USING VITROS MICROWELL ASSAYS INCLUDING THE VITROS ANTI-HCV ASSAY WHEN THE EVENT OCCURRED. DUE TO THE POTENTIAL PATHOGEN CONTENTS AND PATHOGEN CONCENTRATIONS IN THE MICROWELL, A POTENTIAL TRANSMISSION OF BLOOD BORNE PATHOGEN VIA THIS INCIDENT CANNOT BE EXCLUDED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER 32231870 AND REPORTABILITY ASSESSMENT 604909.

  Patient problems: Exposure to Body Fluids

  MAUDE report 18721489 ↗
• MalfunctionApr 27, 2023False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT FALSE NON-REACTIVE PATIENT SAMPLE RESULTS WERE OBTAINED WHEN A SINGLE PATIENT SAMPLE THAT WAS TESTED USING VITROS ANTI-HCV (AHCV) LOT 5320 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE PATIENT WAS KNOWN TO BE INFECTED WITH HEPATITIS C, THEREFORE THE VITROS AHCV RESULTS ARE FALSE NON-REACTIVE RESULTS. PATIENT 1, VITROS AHCV RESULTS OF 0.74 AND 0.65 S/C (NON-REACTIVE) VERSUS THE EXPECTED RESULT OF REACTIVE BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REACTIVE VITROS AHCV RESULTS FOR PATIENT 1 WERE NOT REPORTED FROM THE LABORATORY. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION 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 601630.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16822744 ↗