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VITROS 1926740Recalls & reported problems

Ortho-Clinical Diagnostics, Inc. · VITROS Chemistry Products CRP 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. Oct 11, 2024Open, Classified

    May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to know if the sample has to be diluted to measure again.

    Z-0535-2025 · Root cause: Under Investigation by firm · FDA record ↗

Other C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL devices

All C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL devices →

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