Dimension® clinical chemistry system TPSA Flex® reagent cartridge 10444889Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00842768013874), received between Jan 31, 2020 and May 13, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “High Test Results” (12 reports).

2 other recalls cover devices cleared under the same FDA submission (P000021); 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) RESULT ON A PATIENT PLASMA SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE SERUM SAMPLE FOR THE SAME PATIENT WAS PROCESSED ON AN ALTERNATE NON-SIEMENS METHOD AT AN ALTERNATE SITE. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22012062 ↗
• MalfunctionFeb 12, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FOUR (4) ERRONEOUSLY ELEVATED TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) PATIENT SAMPLE RESULTS OBTAINED ON A DIMENSION EXL 200 SYSTEM. THE ERRONEOUSLY ELEVATED SAMPLE RESULTS WERE REPORTED TO THE PHYSICIAN AND NOT QUESTIONED. A DIFFERENT SAMPLE HAD PREVIOUSLY BEEN PROCESSED ON AN ALTERNATE SIEMENS ATELLICA IM 1300 ANALYZER AT AN ALTERNATE FACILITY. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. DUE TO THE ERRONEOUSLY ELEVATED TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) RESULTS, THE PATIENT HAD MULTIPLE REPEAT BLOOD TESTS PERFORMED AND A POSITRON EMISSION TOMOGRAPHY (PET) SCAN. THERE WAS NO HARM CAUSED TO THE PATIENT DUE TO THE ERRONEOUSLY ELEVATED TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367646 ↗
• MalfunctionFeb 12, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED ONE (1) ERRONEOUSLY ELEVATED TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) PATIENT SAMPLE RESULT OBTAINED ON A DIMENSION EXL 200 SYSTEM. THE ERRONEOUSLY ELEVATED SAMPLE RESULT WAS REPORTED TO THE PHYSICIAN AND WAS NOT QUESTIONED. A NEW SAMPLE WAS PROCESSED ON AN ALTERNATE SIEMENS ATELLICA IM 1300 ANALYZER AT AN ALTERNATE FACILITY. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. DUE TO THE ERRONEOUSLY ELEVATED TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) RESULT, THE PATIENT HAD MULTIPLE REPEAT BLOOD TESTS PERFORMED AND A POSITRON EMISSION TOMOGRAPHY (PET) SCAN. THERE WAS NO HARM CAUSED TO THE PATIENT DUE TO THE ERRONEOUSLY ELEVATED TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367631 ↗
• MalfunctionFeb 12, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TWO (2) ERRONEOUSLY ELEVATED TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) RESULTS FROM THE SAME PATIENT SAMPLE OBTAINED ON A DIMENSION EXL 200 SYSTEM. THE ERRONEOUSLY ELEVATED SAMPLE RESULTS WERE REPORTED TO THE PHYSICIAN AND NOT QUESTIONED. THE SAME SAMPLE WAS PROCESSED ON AN ALTERNATE SIEMENS ATELLICA IM 1300 ANALYZER AT AN ALTERNATE FACILITY. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. DUE TO THE ERRONEOUSLY ELEVATED TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) RESULTS, THE PATIENT HAD MULTIPLE REPEAT BLOOD TESTS PERFORMED AND A POSITRON EMISSION TOMOGRAPHY (PET) SCAN. THERE WAS NO HARM CAUSED TO THE PATIENT DUE TO THE ERRONEOUSLY ELEVATED TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367616 ↗
• MalfunctionFeb 12, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED ONE (1) ERRONEOUSLY ELEVATED TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) PATIENT SAMPLE RESULT OBTAINED ON A DIMENSION EXL 200 SYSTEM. THE ERRONEOUSLY ELEVATED SAMPLE RESULT WAS REPORTED TO THE PHYSICIAN AND NOT QUESTIONED. A NEW SAMPLE WAS DRAWN AND PROCESSED ON AN ALTERNATE SIEMENS ATELLICA IM 1300 ANALYZER AT AN ALTERNATE FACILITY. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. DUE TO THE ERRONEOUSLY ELEVATED TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) RESULT, THE PATIENT HAD MULTIPLE REPEAT BLOOD TESTS PERFORMED AND A POSITRON EMISSION TOMOGRAPHY (PET) SCAN. THERE WAS NO HARM CAUSED TO THE PATIENT DUE TO THE ERRONEOUSLY ELEVATED TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367605 ↗
• MalfunctionJul 11, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ABNORMAL ASSAY FLAG WITH A TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) PATIENT SAMPLE RESULT ON A DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM. THE ABNORMAL ASSAY FLAGGED RESULT WAS REPORTED TO THE PHYSICIAN AND WAS NOT QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM AFTER TROUBLESHOOTING AND A RESULT WAS OBTAINED WITHOUT AN ABNORMAL ASSAY FLAG. THE REPROCESSED RESULT WITHOUT A FLAG WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE IS NO ALLEGATION OF UNNECESSARY TREATMENT DUE TO THE REPORTING THE ABNORMAL ASSAY FLAGGED RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ABNORMAL ASSAY FLAG WITH THE TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19718908 ↗
• MalfunctionNov 23, 2021High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) RESULT WAS OBTAINED ON A PATIENT SAMPLE PROCESSED ON A DIMENSION EXL WITH LM SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE, NON-SIEMENS SYSTEM AND A LOWER RESULT, CONSIDERED CORRECT, WAS OBTAINED. A CORRECTED REPORT WS ISSUED. THE CUSTOMER STATED THE PATIENT HAD A UROLOGY BIOPSY PERFORMED (DATE NOT PROVIDED). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED TPSA RESULT OR THE BIOPSY PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860287 ↗
• MalfunctionNov 23, 2021High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) RESULT WAS OBTAINED ON A PATIENT SAMPLE PROCESSED ON A DIMENSION EXL WITH LM SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS PROCESSED ON AN ALTERNATE DIMENSION EXL AND A FALSELY ELEVATED RESULT WAS ALSO OBTAINED. THE CUSTOMER STATED THE PATIENT HAD A UROLOGY BIOPSY PERFORMED (DATE NOT PROVIDED). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED TPSA RESULT OR THE BIOPSY PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860285 ↗
• MalfunctionJun 16, 2021High Test Results; High Test Results

  A DISCORDANT ELEVATED TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL W/LM SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE NON-SIEMENS SYSTEM AND A LOWER RESULT WAS OBTAINED. NO CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED TPSA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009246 ↗
• MalfunctionJun 16, 2021High Test Results; High Test Results

  A DISCORDANT ELEVATED TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL W/LM SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE NON-SIEMENS SYSTEM AND A LOWER RESULT WAS OBTAINED. NO CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED TPSA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009199 ↗
• MalfunctionJan 31, 2020High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 SYSTEM. THIS RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WHEN FIRST PROCESSED ON THE SAME DAY HAD RECOVERED A BELOW ASSAY RANGE VALUE. THE PHYSICIAN DID NOT QUESTION THE DISCORDANT FALSELY ELEVATED RESULT WHICH WAS OBTAINED ON A DILUTION OF THE SAME SAMPLE MADE WITH A CONTROL MATERIAL. A POSITRON EMISSION TOMOGRAPHY (PET) SCAN WAS PERFORMED ON THE PATIENT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED TPSA RESULT OR THE PET SCAN.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9652926 ↗
• MalfunctionJan 31, 2020High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 SYSTEM. THIS RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WHEN FIRST PROCESSED ON THE SAME DAY HAD RECOVERED A BELOW ASSAY RANGE VALUE. THE ELEVATED RESULT WAS NOT QUESTIONED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED TPSA RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9652921 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P000021. One submission often covers many models, so check the product and lot details in each record.

• Z-1606-2008 · Mar 24, 2008 · Terminated
  Dimension Total Prostate Specific Antigen (TPSA) Flex Reagent Cartridge (RF451). Siemens, Newark, DE 19714
• Z-0873-03 · Apr 21, 2003 · Terminated
  Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges per carton.