Dimension Vista® Flex® reagent cartridge DIGXN 10488927Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00842768028335), received between Dec 11, 2017 and Dec 11, 2017 — classified as 15 malfunctions.

The most frequently reported specific device problem is “High Test Results” (15 reports).

2 other recalls cover devices cleared under the same FDA submission (K093441); 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. 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED DIGOXIN (DIGXN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A NEW SAMPLE WAS TESTED EARLIER AND REPEATED ON AN ALTERNATE VISTA INSTRUMENT AND HIGH RESULTS WERE OBTAINED. A NEW SAMPLE WAS DRAWN AND TESTED AGAIN ON AN ALTERNATE VISTA INSTRUMENT AND A HIGH RESULT WAS OBTAINED. A NEW SAMPLE WAS DRAWN AND TESTED AT AN ALTERNATE FACILITY USING AN ALTERNATE METHODOLOGY AND A LOWER RESULT WAS OBTAINED. THERE IS NO KNOWN REPORT OF PATIENT ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED DIGXN RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7104090 ↗
• MalfunctionDec 11, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED DIGOXIN (DIGXN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND A HIGH RESULT WAS OBTAINED. A NEW DRAW WAS TESTED ON THE SAME INSTRUMENT AND AN ALTERNATE VISTA INSTRUMENT AND HIGH RESULTS WERE OBTAINED. THERE IS NO KNOWN REPORT OF PATIENT ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED DIGXN RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7104083 ↗
• MalfunctionDec 11, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED DIGOXIN (DIGXN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THERE IS NO KNOWN REPORT OF PATIENT ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED DIGXN RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7104081 ↗
• MalfunctionDec 11, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED DIGOXIN (DIGXN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THERE IS NO KNOWN REPORT OF PATIENT ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED DIGXN RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7104077 ↗
• MalfunctionDec 11, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED DIGOXIN (DIGXN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THERE IS NO KNOWN REPORT OF PATIENT ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED DIGXN RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7103749 ↗
• MalfunctionDec 11, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED DIGOXIN (DIGXN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPEATED TWICE ON THE SAME INSTRUMENT AND HIGH RESULTS WERE OBTAINED. THERE IS NO KNOWN REPORT OF PATIENT ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED DIGXN RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7103748 ↗
• MalfunctionDec 11, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED DIGOXIN (DIGXN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS TESTED TWICE EARLIER ON AN ALTERNATE VISTA INSTRUMENT AND HIGH RESULTS WERE OBTAINED. THE SAME SAMPLE WAS REPEATED THREE TIMES LATER ON THE SAME VISTA INSTRUMENT AND HIGH RESULTS WERE OBTAINED. A 1:3 AND 1:2 MANUAL DILUTION WAS PERFORMED ON THE LAST TWO REPEATS AND HIGH RESULTS WERE OBTAINED ON THE SAME SAMPLE. THE CLINICIAN STARTED TO QUESTION THE RESULT SINCE IT HAD INCREASED WHEN NO DIGOXIN WAS GIVEN TO THE PATIENT. THERE IS NO KNOWN REPORT OF PATIENT ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED DIGXN RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7103746 ↗
• MalfunctionDec 11, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED DIGOXIN (DIGXN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THERE IS NO KNOWN REPORT OF PATIENT ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED DIGXN RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7103745 ↗
• MalfunctionDec 11, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED DIGOXIN (DIGXN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THERE IS NO KNOWN REPORT OF PATIENT ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED DIGXN RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7103744 ↗
• MalfunctionDec 11, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED DIGOXIN (DIGXN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPEATED EARLIER ON AN ALTERNATE VISTA INSTRUMENT AND A HIGH RESULT WAS OBTAINED. THERE IS NO KNOWN REPORT OF PATIENT ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED DIGXN RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7103743 ↗
• MalfunctionDec 11, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED DIGOXIN (DIGXN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THERE IS NO KNOWN REPORT OF PATIENT ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED DIGXN RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7103741 ↗
• MalfunctionDec 11, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED DIGOXIN (DIGXN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND A HIGH RESULT WAS OBTAINED. A NEW SAMPLE WAS DRAWN AND REPEATED ON THE SAME INSTRUMENT AND ON AN ALTERNATE VISTA AND A HIGH RESULT WAS OBTAINED. THERE IS NO KNOWN REPORT OF PATIENT ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED DIGXN RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7103740 ↗
• MalfunctionDec 11, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED DIGOXIN (DIGXN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THERE IS NO KNOWN REPORT OF PATIENT ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED DIGXN RESULT OR THE TREATMENT CANCELLATION. THERE WAS NO HARM TO THE PATIENT RELATED TO THE USE OF THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7103739 ↗
• MalfunctionDec 11, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED DIGOXIN (DIGXN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THERE IS NO KNOWN REPORT OF PATIENT ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED DIGXN RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7103736 ↗
• MalfunctionDec 11, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED DIGOXIN (DIGXN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND A HIGH RESULT WAS OBTAINED. THERE IS NO KNOWN REPORT OF PATIENT ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED DIGXN RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7103735 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093441. One submission often covers many models, so check the product and lot details in each record.

• Z-2607-2017 · Mar 21, 2017 · Terminated
  Dimension Vista Digoxin (DIGXN) Flex reagent cartridge
• Z-1151-2013 · Feb 21, 2013 · Terminated
  Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.