VITROS 6802914Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

6 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 3.8.0 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 ↗

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 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 ↗

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

5. Feb 20, 2019Terminated

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

   Z-1290-2019 · Root cause: Software design · FDA record ↗

6. 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 ↗