VITROS 6199949Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10758750033584), received between Dec 15, 2022 and Dec 15, 2022 — classified as 1 malfunction.

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

2 FDA recall records 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Feb 12, 2021Terminated

   VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media

   Z-1266-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Feb 12, 2021Terminated

   VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media

   Z-1267-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionDec 15, 2022False Positive Result; False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT REACTIVE VITROS SARS-COV-2 ANTIGEN (CV2AG) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED USING VITROS CV2AG LOT 2040 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED DISCORDANT AS A NEGATIVE PCR RESULT WAS OBTAINED FOR THE PATIENT. ADDITIONALLY, A NON-REACTIVE VITROS CV2AG RESULT WAS OBTAINED WHEN THE SAMPLE FROM THE PATIENT WAS RETESTED. VITROS CV2AG RESULTS OF REACTIVE (1.31 AND 1.07 S/C) VERSUS EXPECTED RESULT OF NON-REACTIVE BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE FALSE REACTIVE VITROS CV2AG RESULTS WERE REPORTED FROM THE LABORATORY TO A PHYSICIAN. HOWEVER, NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE REPORTED RESULTS. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 600315.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15992194 ↗