Vista COV2T Assay 11417414Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414605500), received between Mar 26, 2021 and May 14, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Negative 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2021False Positive Result; False Positive Result

  THE CUSTOMER CONSIDERED A POSITIVE DIMENSION VISTA SARS-COV-2 TOTAL ANTIBODY (COV2T) RESULT ON A PATIENT SAMPLE PROCESSED ON A DIMENSION VISTA 1500 SYSTEM TO BE DISCORDANT. THE PATIENT RESULT WAS REPORTED TO THE PHYSICIAN. THE SAME PATIENT SAMPLE WAS PROCESSED ON A NON-SIEMENS INSTRUMENT SYSTEM USING AN IMMUNGLOBULIN G (IGG) METHODOLOGY. A NEGATIVE RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DIMENSION VISTA COV2T PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11824527 ↗
• MalfunctionMar 26, 2021False Negative Result; False Negative Result

  THE CUSTOMER OBTAINED A DISCORDANT NONREACTIVE (NEGATIVE) DIMENSION VISTA SARS-COV-2 TOTAL ANTIBODY (COV2T) RESULT ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED FOR CONFIRMATION OF THE COV2T RESULT ON A LATER DATE AFTER THE INITIAL RESULT WAS QUESTIONED BY THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION VISTA SYSTEM AND ON A SECOND DIMENSION VISTA SYSTEM. THE RESULT WAS NEGATIVE ON BOTH SYSTEMS. THE SAME SAMPLE WAS THEN PROCESSED WITH AN ALTERNATE SIEMENS METHODOLOGY ON A SIEMENS ATELLICA SYSTEM AND A REACTIVE (POSITIVE) RESULT WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DIMENSION VISTA COV2T RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11573997 ↗