Dimension Vista® Flex® reagent cartridge CA 10445160Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00842768015618), received between Nov 1, 2017 and Sep 21, 2026 — classified as 49 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (48 reports).

2 other recalls cover devices cleared under the same FDA submission (K061792); 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 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Low Test Results

  The customer reported that erroneously depressed Calcium (Ca) results on two patient samples were obtained on a Dimension Vista 1500 System. For sample ID (b)(6), the initial result was not reported to the physician. This sample was repeated on an alternate Dimension Vista 1500 System. While the initial result of sample ID (b)(6) was reported to the physician and not questioned. This sample was repeated on both original and on alternate Dimension Vista 1500 Systems. All the repeat results obtained were higher, correlated clinically, and considered correct. The repeat results from alternate system were reported to the physician. There are no known reports of patient intervention or adverse health consequences due to the reported event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50835272 ↗
• MalfunctionNov 8, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED CALCIUM (CA) RESULT ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 INTELLIGENT LAB SYSTEM. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN AS IT FAILED THE DELTA CHECK BUT WAS CONSIDERED CORRECT. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION VISTA 500 INTELLIGENT LAB SYSTEM, AND A HIGHER RESULT WAS OBTAINED, WHICH WAS CONSIDERED ERRONEOUS AND NOT REPORTED TO THE PHYSICIAN. THEN, THE SAME SAMPLE WAS REPROCESSED THRICE ON THE ORIGINAL DIMENSION VISTA 500 INTELLIGENT LAB SYSTEM, AND LOWER RESULTS COMPARED TO THE ERRONEOUS RESULT WERE OBTAINED, WHICH MATCHED THE PATIENT¿S CLINICAL PICTURE. A RESULT OF 8.4 MG/DL WAS REPORTED TO THE PHYSICIAN AS A CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED CALCIUM (CA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20640321 ↗
• MalfunctionFeb 16, 2018Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CALCIUM (CA) RESULTS WERE OBTAINED ON QUALITY CONTROL SAMPLES ON THE DIMENSION VISTA 1500 INSTRUMENT S/N (B)(4). THE CUSTOMER STATED THERE WAS NO IMPACT ON THE PATIENT RESULTS. THERE IS NO KNOWN REPORT OF ANY DELAYS IN REPORTING, PATIENT INTERVENTION, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CA QC RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7278572 ↗
• MalfunctionFeb 16, 2018High Test Results; Low Test Results; High Test Results; Low Test Results

  DISCORDANT IMPRECISE AND OUT OF RANGE CALCIUM (CA) RESULTS WERE OBTAINED ON QUALITY CONTROL SAMPLES ON THE DIMENSION VISTA 1500 INSTRUMENT S/N (B)(4). THE CUSTOMER STATED THERE WAS NO IMPACT ON THE PATIENT RESULTS. THERE IS NO KNOWN REPORT OF ANY DELAYS IN REPORTING, PATIENT INTERVENTION, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IMPRECISE AND OUT OF RANGE CA QC RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7278567 ↗
• MalfunctionFeb 16, 2018Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CALCIUM (CA) RESULTS WERE OBTAINED ON QUALITY CONTROL SAMPLES ON THE DIMENSION VISTA 1500 INSTRUMENT S/N (B)(4). THE CUSTOMER STATED THERE WAS NO IMPACT ON THE PATIENT RESULTS. THERE IS NO KNOWN REPORT OF ANY DELAYS IN REPORTING, PATIENT INTERVENTION, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CA QC RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7278565 ↗
• MalfunctionFeb 16, 2018Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CALCIUM (CA) RESULTS WERE OBTAINED ON QUALITY CONTROL SAMPLES ON THE DIMENSION VISTA 1500 INSTRUMENT S/N (B)(4). THE CUSTOMER STATED THERE WAS NO IMPACT ON THE PATIENT RESULTS. THERE IS NO KNOWN REPORT OF ANY DELAYS IN REPORTING, PATIENT INTERVENTION, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CA QC RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7278563 ↗
• MalfunctionFeb 9, 2018Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CALCIUM (CA) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND NOT QUESTIONED. THE SAME SAMPLES WERE REPEATED ON THE SAME DIMENSION VISTA INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. CORRECTED RESULTS WERE REPORTED. THERE IS NO KNOWN REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7261700 ↗
• MalfunctionFeb 9, 2018Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CALCIUM (CA) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION VISTA 500 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. CORRECTED RESULTS WERE REPORTED. THERE IS NO KNOWN REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7261184 ↗
• MalfunctionFeb 9, 2018Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CALCIUM (CA) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION VISTA 500 INSTRUMENT. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT AND HIGHER RESULTS WERE OBTAINED AND REPORTED. THERE IS NO KNOWN REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7261159 ↗
• MalfunctionFeb 9, 2018Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CALCIUM (CA) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE SAME SAMPLES WERE REPEATED ON THE SAME OR AN ALTERNATE DIMENSION VISTA INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. CORRECTED RESULTS WERE REPORTED. THERE IS NO KNOWN REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7261158 ↗
• MalfunctionFeb 9, 2018Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CALCIUM (CA) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND NOT QUESTIONED. THE SAME SAMPLES WERE REPEATED ON THE SAME INSTRUMENT WITH A DIFFERENT REAGENT WELL SET AND HIGHER RESULTS WERE OBTAINED. CORRECTED RESULTS WERE REPORTED. THERE IS NO KNOWN REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7261154 ↗
• MalfunctionFeb 9, 2018Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CALCIUM (CA) RESULTS WERE OBTAINED ON QC AND PATIENT SAMPLES ON THE DIMENSION VISTA 500 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND NOT QUESTIONED. THE SAME SAMPLES WERE REPEATED AND HIGHER RESULTS WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. THERE IS NO KNOWN REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7260575 ↗
• MalfunctionFeb 9, 2018Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CALCIUM (CA) RESULTS WERE OBTAINED ON QC AND PATIENT SAMPLES ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPEATED ON BOTH THE SAME AND AN ALTERNATE DIMENSION VISTA INSTRUMENT AND HIGHER RESULTS WERE OBTAINED AND REPORTED. THERE IS NO KNOWN REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7260540 ↗
• MalfunctionFeb 9, 2018Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CALCIUM (CA) RESULTS WERE OBTAINED ON QC AND PATIENT SAMPLES ON THE DIMENSION VISTA 500 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND NOT QUESTIONED. THE SAME SAMPLES WERE REPEATED AFTER QC WAS NOTED TO BE OUT OF RANGE AND HIGHER RESULTS WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. THERE IS NO KNOWN REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7260539 ↗
• MalfunctionFeb 9, 2018Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CALCIUM (CA) RESULTS WERE OBTAINED ON QC AND A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE PATIENT RESULT WAS REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPEATED ON THE SAME INSTRUMENT WITH AN ALTERNATE LOT OF REAGENT AND A HIGHER RESULTS WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THERE IS NO KNOWN REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7260137 ↗
• MalfunctionFeb 9, 2018Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED AND FALSELY ELEVATED CALCIUM (CA) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND NOT QUESTIONED. THE SAME SAMPLES WERE REPEATED ON THE SAME DIMENSION VISTA INSTRUMENT AND DIFFERENT RESULTS WERE OBTAINED. CORRECTED RESULTS WERE REPORTED FOR SOME SAMPLES. THERE IS NO KNOWN REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED AND FALSELY ELEVATED CA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7260136 ↗
• MalfunctionFeb 9, 2018Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CALCIUM (CA) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND NOT QUESTIONED. THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. CORRECTED RESULTS WERE REPORTED. THERE IS NO KNOWN REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7260130 ↗
• MalfunctionFeb 9, 2018Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED CALCIUM (CA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPEATED ON THE SAME DIMENSION VISTA INSTRUMENT AND A HIGHER RESULT WAS OBTAINED AND REPORTED. THERE IS NO KNOWN REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7260129 ↗
• MalfunctionFeb 9, 2018Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CALCIUM (CA) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION VISTA 1500 INSTRUMENT. THE PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE NOT QUESTIONED. THE SAME SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. THERE IS NO KNOWN REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7260118 ↗
• MalfunctionFeb 9, 2018Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CALCIUM (CA) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE SAME SAMPLES WERE REPEATED AND HIGHER RESULTS WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. THERE IS NO KNOWN REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7260028 ↗
• MalfunctionFeb 9, 2018Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED CALCIUM (CA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT AND A HIGHER RESULT WAS OBTAINED AND REPORTED AS IT WAS CONSISTENT WITH CUSTOMER EXPECTATIONS. THERE IS NO KNOWN REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7260026 ↗
• MalfunctionFeb 9, 2018Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CALCIUM (CA) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND NOT QUESTIONED. THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. CORRECTED RESULTS WERE REPORTED. THERE IS NO KNOWN REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7260024 ↗
• MalfunctionFeb 8, 2018Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CALCIUM (CA) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION VISTA 1500 INSTRUMENT S/N (B)(4). THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPEATED ON ALTERNATE DIMENSION VISTA INSTRUMENTS AND HIGHER RESULTS WERE OBTAINED AND REPORTED. THERE IS NO KNOWN REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7255126 ↗
• MalfunctionFeb 8, 2018Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CALCIUM (CA) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND NOT QUESTIONED. THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. CORRECTED RESULTS WERE REPORTED. THERE IS NO KNOWN REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7253169 ↗
• MalfunctionFeb 8, 2018Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED CALCIUM (CA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPEATED ON THE SAME DIMENSION VISTA INSTRUMENT AND A HIGHER RESULT WAS OBTAINED AND REPORTED. THERE IS NO KNOWN REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7253055 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061792. One submission often covers many models, so check the product and lot details in each record.

• Z-1540-2018 · Jan 30, 2018 · Terminated
  Dimension Vista Calcium Flex reagent cartridge, Dimension Vista CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium
• Z-0039-2017 · Aug 3, 2016 · Terminated
  Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB