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VITROS 1053180Recalls & reported problems

Ortho-Clinical Diagnostics, Inc. · VITROS Chemistry Products ALKP Slides · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

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

1 FDA recall record name this device's identifier, 1 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. 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-2624-2023 · Root cause: Under Investigation by firm · FDA record ↗

Other NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES devices

All NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.