VITROS 6802915Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10758750007110), received between Aug 23, 2023 and Dec 9, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 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. 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 · 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-1226-2024 · Root cause: Software Design Change · FDA record ↗

3. 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-1221-2024 · Root cause: Component change control · FDA record ↗

4. 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-0545-2024 · Root cause: Under Investigation by firm · FDA record ↗

5. Mar 10, 2023Open, Classified

   MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable

   Z-1557-2023 · Root cause: Under Investigation by firm · FDA record ↗

6. Jul 8, 2019Terminated

   Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

   Z-2180-2019 · Root cause: Software design · FDA record ↗

7. Feb 20, 2019Terminated

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

   Z-1288-2019 · Root cause: Software design · FDA record ↗

8. Oct 19, 2018Terminated

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

   Z-0650-2019 · Root cause: Software Manufacturing/Software Deployment · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE VITROS PERFORMANCE VERIFIER (PV) I LOT E2828 QUALITY CONTROL FLUID, USING VITROS NA+ SLIDE LOT 4282-1162-2951 ON A VITROS 5600 INTEGRATED SYSTEM. VITROS PV I LOT E2828 NA+ RESULTS OF 145.5, 146.1, 143.3 AND 145.4 MMOL/L VS. THE EXPECTED RESULT OF 126.2 MMOL/L 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 NA+ SLIDE LOT 4282-1162-2951 RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. 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) AND REPORTABILITY ASSESSMENT 612777.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756097 ↗
• MalfunctionAug 29, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED NT-PROBNP II (NTBNP II) RESULTS WERE OBTAINED WHEN PROCESSING A NONVITROS BIORAD QUALITY CONTROL (QC) FLUID ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 1 RESULTS OF 127.3, 155.5,227.3, 174.99 AND 176.02 PG/ML VS EXPECTED RESULT OF 59.9 PG/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 NTBNP II RESULTS WERE OBTAINED WHEN PROCESSING NON-VITROS QC FLUID. THE CUSTOMER MADE NO INDICATION THAT ANY PATIENT SAMPLE RESULTS HAD BEEN AFFECTED. THERE WERE NO REPORTED ALLEGATIONS OF 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 17644843 ↗
• MalfunctionAug 23, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM NON-VITROS (BIORAD) QC FLUIDS WHEN PROCESSED USING VITROS TSH LOT 7070, VITROS B-HCG II LOT 3720 AND VITROS PSA LOT 4330 ON A REFURBISHED VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 85311 LEVEL 1, VITROS TSH RESULT OF 0.461 MIU/L VERSUS THE BASELINE MEAN RESULT OF 0.660 MIU/L BIORAD LOT 85313 LEVEL 3, VITROS TSH RESULT OF 15.949 MIU/L VERSUS THE BASELINE MEAN RESULT OF 26.330 MIU/L BIORAD LOT 85313 LEVEL 3, VITROS B-HCG II RESULT OF 350.203 MIU/ML VERSUS THE BASELINE MEAN RESULT OF 537.5 MIU/ML BIORAD LOT 85313 LEVEL 3, VITROS PSA RESULT OF 9.694 NG/ML VERSUS THE BASELINE MEAN RESULT OF 15.860 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 LOWER THAN EXPECTED VITROS TSH, VITROS B-HCG II AND VITROS PSA RESULTS WERE GENERATED WHEN THE CUSTOMER WAS PROCESSING NON-PATIENT FLUIDS. 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 (OR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17607681 ↗