Dimension Vista® Flex® reagent cartridge TBIL 10445146Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00842768015717), received between Aug 22, 2018 and Jan 16, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K061719); they may or may not involve this specific model.

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. Jul 30, 2024Open, Classified

   During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an issue with the filling line which led to some wells to underfill in lot 23206BA. Calibrator, quality control (QC) and patient results could have been impacted.

   Z-3065-2024 · Root cause: Software Manufacturing/Software Deployment · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2024Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED TOTAL BILIRUBIN (TBIL) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 500 SYSTEM. THE FALSELY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION VISTA 500 SYSTEM AND OBTAINED HIGHER RESULT. THE REPROCESSED RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED TOTAL BILIRUBIN (TBIL) PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18520164 ↗
• MalfunctionJan 16, 2024Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED TOTAL BILIRUBIN (TBIL) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 500 SYSTEM. THE FALSELY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION VISTA 500 SYSTEM AND OBTAINED HIGHER RESULT. THE REPROCESSED RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED TOTAL BILIRUBIN (TBIL) PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519481 ↗
• MalfunctionJan 16, 2024Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED TOTAL BILIRUBIN (TBIL) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 500 SYSTEM. THE FALSELY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION VISTA 500 SYSTEM AND OBTAINED HIGHER RESULT. THE REPROCESSED RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED TOTAL BILIRUBIN (TBIL) PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518987 ↗
• MalfunctionJan 16, 2024Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED TOTAL BILIRUBIN (TBIL) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 500 SYSTEM. THE FALSELY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION VISTA 500 SYSTEM AND OBTAINED HIGHER RESULT. THE REPROCESSED RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED TOTAL BILIRUBIN (TBIL) PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518982 ↗
• MalfunctionDec 20, 2018Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED TOTAL BILIRUBIN RESULT WITH A E111 HEMOLYSIS ERROR FLAG WAS OBTAINED ON A NEONATE PATIENT SAMPLE ON THE DIMENSION VISTA INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. A NEW SAMPLE DRAWN FROM THE SAME PATIENT WAS PROCESSED THE NEXT DAY ON THE ORIGINAL INSTRUMENT AND A HIGHER RESULT WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED TOTAL BILIRUBIN (TBIL) RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8185331 ↗
• MalfunctionAug 22, 2018Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED TOTAL BILIRUBIN (TBIL) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 SYSTEM. THE RESULT WAS FLAGGED FOR HEMOLYSIS (E111 FLAG) BUT WAS REPORTED TO THE PHYSICIAN. A NEW SAMPLE DRAWN THE SAME DAY WAS PROCESSED AND A HIGHER RESULT WAS OBTAINED CONSISTENT WITH THE CLINICAL PICTURE AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED TBIL RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7806495 ↗
• MalfunctionAug 22, 2018Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED TOTAL BILIRUBIN (TBIL) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 SYSTEM. THE RESULT WAS FLAGGED FOR HEMOLYSIS (E111 FLAG) BUT WAS REPORTED TO THE PHYSICIAN. A NEW SAMPLE DRAWN THE SAME DAY WAS PROCESSED AND A HIGHER RESULT WAS OBTAINED CONSISTENT WITH THE CLINICAL PICTURE AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED TBIL RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7806482 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061719. One submission often covers many models, so check the product and lot details in each record.

• Z-1541-2020 · Feb 13, 2020 · Terminated
  Dimension Vista Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10445146 Product Usage: Dimension Vista TBIL method is