Dimension Vista® Flex® reagent cartridge ECREA 10700444Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00842768036262), received between Jun 11, 2020 and Apr 20, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (6 reports).

1 FDA recall record name this device's identifier.

4 other recalls cover devices cleared under the same FDA submission (K090330); 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.

Recalls naming this device

1. Dec 18, 2019Class IITerminated

   There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.

   Z-1233-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2022Low Test Results; Low Test Results

  THREE (3) DISCORDANT FALSELY DEPRESSED ENZYMATIC CREATININE (ECREA) PATIENT SAMPLE RESULTS WERE OBTAINED ON A DIMENSION VISTA 1500 SYSTEM. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE SAME SYSTEM AND HIGHER ECREA RESULTS, CONSIDERED CORRECT, WERE OBTAINED. ADDITIONALLY, THE HIGHER REPROCESSED RESULTS WERE VERIFIED WITH AN ALTERNATE DIMENSION VISTA SYSTEM. THE REPROCESSED ECREA RESULTS FROM THE INITIAL DIMENSION VISTA SYSTEM WERE REPORTED AS THE CORRECT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED ENZYMATIC CREATININE (ECREA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14159584 ↗
• MalfunctionFeb 3, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED PATIENT SAMPLE RESULT WAS OBTAINED FOR ENZYMATIC CREATININE (ECREA) ON A DIMENSION VISTA 500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED AFTER A RECALIBRATION OF THE ASSAY AND A HIGHER ECREA RESULT, CONSIDERED CORRECT, 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 ECREA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11273410 ↗
• MalfunctionJan 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISCORDANT, FALSELY DEPRESSED PATIENT SAMPLE RESULTS WERE OBTAINED FOR ENZYMATIC CREATININE (ECREA) ON A DIMENSION VISTA 1500 SYSTEM. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED AFTER AN ADJUSTMENT TO THE DIGITS OF PRECISION SETTING ON THE INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. CORRECTED RESULTS WERE REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ECREA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11209272 ↗
• MalfunctionJan 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISCORDANT, FALSELY DEPRESSED PATIENT SAMPLE RESULTS WERE OBTAINED FOR ENZYMATIC CREATININE (ECREA) ON A DIMENSION VISTA 1500 SYSTEM. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED AFTER AN ADJUSTMENT TO THE DIGITS OF PRECISION SETTING ON THE INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. CORRECTED RESULTS WERE REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ECREA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11209271 ↗
• MalfunctionJan 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISCORDANT, FALSELY DEPRESSED PATIENT SAMPLE RESULTS WERE OBTAINED FOR ENZYMATIC CREATININE (ECREA) ON A DIMENSION VISTA 1500 SYSTEM. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED AFTER AN ADJUSTMENT TO THE DIGITS OF PRECISION SETTING ON THE INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. CORRECTED RESULTS WERE REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ECREA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11209266 ↗
• MalfunctionJan 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISCORDANT, FALSELY DEPRESSED PATIENT SAMPLE RESULTS WERE OBTAINED FOR ENZYMATIC CREATININE (ECREA) ON A DIMENSION VISTA 1500 SYSTEM. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED AFTER AN ADJUSTMENT TO THE DIGITS OF PRECISION SETTING ON THE INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. CORRECTED RESULTS WERE REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ECREA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11209263 ↗
• MalfunctionJan 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISCORDANT, FALSELY DEPRESSED PATIENT SAMPLE RESULTS WERE OBTAINED FOR ENZYMATIC CREATININE (ECREA) ON A DIMENSION VISTA 1500 SYSTEM. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED AFTER AN ADJUSTMENT TO THE DIGITS OF PRECISION SETTING ON THE INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. CORRECTED RESULTS WERE REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ECREA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11209252 ↗
• MalfunctionJan 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A DISCORDANT, FALSELY DEPRESSED PATIENT SAMPLE RESULT WAS OBTAINED FOR ENZYMATIC CREATININE (B)(4). ON A DIMENSION VISTA 1500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED AFTER A CORRECTION TO DIGITS OF PRECISION SETTING WAS MADE AND A HIGHER RESULT WAS OBTAINED. A CORRECTED RESULT WAS REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ECREA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11209170 ↗
• MalfunctionSep 30, 2020Low Test Results; Low Test Results

  SIEMENS INVESTIGATED THE IMPACT OF THE ETAMSYLATE DRUG ON THE DIMENSION VISTA ENZYMATIC CREATININE (ECREA) ASSAY. SIEMENS PROCESSED SAMPLES AT VARYING CONCENTRATIONS (1.50 MG/DL, 3.00 MG/DL, 4.50 MG/DL, AND 6.00 MG/DL) OF ETAMSYLATE FOR ECREA, AND COMPARED THESE RESULTS WITH A SAMPLE WITH NO ETAMSYLATE. SIEMENS OBSERVED THAT THE BIAS WAS GREATEST FOR THE SAMPLE WITH THE ETAMSYLATE CONCENTRATION OF 6.00 MG/DL. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NEGATIVE BIAS OBSERVED IN ECREA RESULTS. ETAMSYLATE (DICYNONE) IS NOT LISTED AS AN INTERFERING SUBSTANCE IN THE DIMENSION ENZYMATIC CREATININE (ECREA) INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10609440 ↗
• MalfunctionJun 11, 2020Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED ENZYMATIC CREATININE (ECREA) RESULT WAS OBTAINED ON A PATIENT PLASMA SAMPLE ON A DIMENSION VISTA 500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE SAME INSTRUMENT AND A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED ECREA RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10143416 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090330. One submission often covers many models, so check the product and lot details in each record.

• Z-2285-2020 · May 4, 2020 · Terminated
  Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use in the quantitative determination of creatinine in human seru
• Z-1664-2016 · Mar 17, 2016 · Terminated
  Dimension Vista Assays: Enzymatic Creatine (ECRE)
• Z-2154-2011 · Jun 10, 2010 · Terminated
  Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension Vista(R) 500 System The ECREA method is an in vitro diagnostic test for the quantitative measuremen
• Z-2419-2010 · Feb 12, 2010 · Terminated
  Dimension Vista ECREA Flex Reagent Cartridge The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the