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VITROS 6801425Recalls & reported problems

Ortho Clinical Diagnostics · VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10758750002795), received between Mar 22, 2023 and Mar 22, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Positive Result” (1 report).

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.

Most reported problems

Device problems

  • False Positive Result1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 22, 2023False Positive Result; False Positive Result

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT REACTIVE VITROS ANTI-HBC IGM (AHBCM) AND ANTI-HAV IGM (AHAVM) RESULTS OBTAINED FROM TWO SAMPLES COLLECTED FROM THE SAME PATIENT COMPARED TO ANTI-HBC TOTAL AND ANTI-HAV TOTAL NEGATIVE RESULTS WERE OBTAINED FROM THE SAME PATIENT SAMPLES WHEN TESTED ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. SAMPLE 1 VITROS AHAVM RESULT OF 10.4 S/C VS. A VITROS AHAV TOTAL NEGATIVE RESULT. SAMPLE 1 VITROS AHBCM RESULT OF 2.87 S/C VS. A VITROS AHBC TOTAL NEGATIVE RESULT. SAMPLE 2 VITROS AHAVM RESULT OF 10.4 S/C VS. A VITROS AHAV TOTAL NEGATIVE RESULT. SAMPLE 2 VITROS AHBCM RESULT OF 2.91 S/C VS. A VITROS AHBC TOTAL NEGATIVE RESULT. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE VITROS AHBCM AND AHAVM REACTIVE RESULTS WERE REPORTED OUTSIDE THE LABORATORY BASED ON THE CONCORDANT RESULTS OBTAINED AT THE MAYO CLINIC. THERE WAS NO REPORTED ALLEGATION OF HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE IN

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16591918 ↗

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