Dimension® Flex® reagent cartridge ALB 10444975Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00842768005343), received between Aug 20, 2019 and Apr 27, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (K861700); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2021Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED SERUM/PLASMA ALBUMIN RESULTS WERE OBTAINED ON PATIENT SAMPLES ON A DIMENSION® EXL¿ 200 SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE CUSTOMER REPROCESSED THE SAME SAMPLES ON TWO ALTERNATE NON-SIEMENS INSTRUMENT SYSTEMS AND HIGHER RESULTS, CONSIDERED CORRECT, WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. THE CUSTOMER STATED THAT THERE WAS SOME DELAY IN OBTAINING RESULTS FOR THE DIALYSIS PATIENTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ALB RESULTS OR THE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732362 ↗
• MalfunctionApr 27, 2021Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED SERUM/PLASMA ALBUMIN RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION® EXL¿ 200 SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE CUSTOMER REPROCESSED THE SAME SAMPLE ON AN ALTERNATE NON-SIEMENS INSTRUMENT SYSTEM AND A HIGHER RESULT, CONSIDERED CORRECT, WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THE CUSTOMER STATED THAT THERE WAS SOME DELAY IN OBTAINING RESULTS FOR THE DIALYSIS PATIENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ALB RESULT OR THE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732354 ↗
• MalfunctionApr 27, 2021Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED SERUM/PLASMA ALBUMIN RESULTS WERE OBTAINED ON PATIENT SAMPLES ON A DIMENSION® EXL¿ 200 SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE CUSTOMER REPROCESSED THE SAME SAMPLES ON TWO ALTERNATE NON-SIEMENS INSTRUMENT SYSTEMS AND HIGHER RESULTS, CONSIDERED CORRECT, WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. THE CUSTOMER STATED THAT THERE WAS SOME DELAY IN OBTAINING RESULTS FOR THE DIALYSIS PATIENTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ALB RESULTS OR THE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732353 ↗
• MalfunctionApr 27, 2021Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED SERUM/PLASMA ALBUMIN RESULT WAS OBTAINED ON THE DIMENSION® EXL¿ 200 SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE CUSTOMER REPROCESSED THE SAME SAMPLE ON AN ALTERNATE NON-SIEMENS INSTRUMENT SYSTEM AND A HIGHER RESULT, CONSIDERED CORRECT, WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THE CUSTOMER STATED THAT THERE WAS SOME DELAY IN OBTAINING RESULTS FOR THE DIALYSIS PATIENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ALB RESULT OR THE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732351 ↗
• MalfunctionApr 27, 2021Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED SERUM/PLASMA ALBUMIN RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION® EXL¿ 200 SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE CUSTOMER REPROCESSED THE SAME SAMPLE ON AN ALTERNATE NON-SIEMENS INSTRUMENT SYSTEM AND A HIGHER RESULT, CONSIDERED CORRECT, WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THE CUSTOMER STATED THAT THERE WAS SOME DELAY IN OBTAINING RESULTS FOR THE DIALYSIS PATIENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ALB RESULT OR THE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732342 ↗
• MalfunctionAug 20, 2019Low Test Results; Low Test Results

  DISCORDANT, FALSELY DEPRESSED ALBUMIN (ALB) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. A NEW SAMPLE WAS PROCESSED USING THE SAME INSTRUMENT AND AN ALTERNATE DIMENSION EXL 200 INSTRUMENT AND LOWER RESULTS WERE OBTAINED. THE NEW SAMPLE WAS ALSO PROCESSED ON AN ALTERNATE NON-SIEMENS INSTRUMENT ON THE SAME DAY AND HIGHER RESULTS WERE OBTAINED. A CORRECTED REPORT WAS ISSUED WITH THE HIGHER RESULTS. THE PATIENT WAS ADMINISTERED AN ALBUMIN INFUSION. THERE WERE NO ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED ALBUMIN RESULTS OR DUE TO TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8911400 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K861700. One submission often covers many models, so check the product and lot details in each record.

• Z-1816-2022 · Aug 17, 2022 · Open, Classified
  Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
• Z-1049-2013 · Feb 22, 2013 · Terminated
  Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) method used on the Dimension(R) clinical chemistry system is an in vitro diagnostic t