VITROS 6844458Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10758750031986), received between Apr 29, 2026 and Jun 1, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 reports).

4 FDA recall records name this device's identifier, 4 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 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

   Z-1227-2024 · Root cause: Software Design Change · FDA record ↗

2. Jan 26, 2024Open, Classified

   A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 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 · FDA record ↗

3. 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-0546-2024 · Root cause: Under Investigation by firm · FDA record ↗

4. Jul 19, 2022Open, Classified

   Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.

   Z-1675-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 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 SODIUM RESULT OBTAINED FROM A SINGLE LEVEL OF VITROS PERFORMANCE VERIFIER (PV) FLUID (LOT K3261) PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4219-1190-2248 ON A VITROS XT 3400 CHEMISTRY SYSTEM. VITROS PV I K3261 RESULT OF 136.4 MMOL/L VS. THE EXPECTED RESULT OF 119.1 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+ RESULT WAS OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID PROCESSED DURING A PRECISION TEST. 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 614622.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25351828 ↗
• MalfunctionApr 29, 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 SODIUM (NA+) RESULTS WERE OBTAINED FROM VITROS PERFORMANCE VERIFIER (PV) I E2828 USING THREE DIFFERENT VITROS NA+ SLIDE LOTS TESTED ON A VITROS XT3400 INTEGRATED SYSTEM. VITROS NA+ SLIDE LOT 4209-1181-9128 VITROS PV I E2828 RESULT OF 140.8 MMOL/L VS. THE BASELINE MEAN OF 126.0 MMOL/L VITROS NA+ SLIDE LOT 4214-1186-0987 VITROS PV I E2828 RESULT OF 158.1, 158.0, 141.9, AND 149.5 MMOL/L VS. THE BASELINE MEAN OF 126.0 MMOL/L VITROS NA+ SLIDE LOT 4220-1191-2809 VITROS PV I E2828 RESULT OF 147.3 MMOL/L VS. THE BASELINE MEAN OF 126.0 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+ RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL 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) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25027363 ↗