VITROS 6844296Recalls & reported problems

Summary

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

4 FDA recall records name this device's identifier, 2 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. 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 · FDA record ↗

2. Aug 5, 2023Open, Classified

   Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.

   Z-2623-2023 · Root cause: Under Investigation by firm · FDA record ↗

3. Jul 13, 2020Terminated

   Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides

   Z-2875-2020 · Root cause: Other · FDA record ↗

4. Jul 13, 2020Terminated

   Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides

   Z-2873-2020 · Root cause: Other · FDA record ↗