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VITROS 6801427Recalls & reported problems

Ortho Clinical Diagnostics · VITROS Immunodiagnostic Products Anti-HBc IgM Controls · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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.

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 15, 2021Terminated

    Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of patient test results is not affected by this issue, there is a potential for delayed results due to the troubleshooting of Quality Control results.

    Z-0247-2022 · Root cause: Under Investigation by firm · FDA record ↗

Other Single (specified) analyte controls (assayed and unassayed) devices

All Single (specified) analyte controls (assayed and unassayed) devices →

Sources and updates

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