Dimension® Flex Reagent Cartridge HB1C 10483822Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842768032615), received between Jun 27, 2018 and Apr 29, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K102510); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2019High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED HEMOGLOBIN A1C (HB1C) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION EXL 200 INSTRUMENT ON (B)(6) 2019. THE RESULTS WERE REPORTED TO THE PHYSICIAN (S) AND WERE QUESTIONED. THE SAME SAMPLES WERE REPROCESSED USING AN ALTERNATE METHODOLOGY ON A NON-SIEMENS INSTRUMENT ON THE SAME DATE AND LOWER HEMOGLOBIN A1C RESULTS WERE OBTAINED. ON (B)(6) 2019, SIEMENS WAS INFORMED THAT THE PHYSICIANS (S) REGARDED THE DIMENSION HB1C RESULTS AS HIGH AND STARTED TREATMENT FOR PRE-DIABETES. THE TYPE OF TREATMENT WAS NOT SPECIFIED. THERE WAS NO ALLEGED PATIENT HARM DUE TO THE DISCORDANT ELEVATED HB1C RESULTS OR DUE TO THE TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8561220 ↗
• MalfunctionJun 27, 2018Device Operational Issue; Device Operational Issue

  DISCORDANT HEMOGLOBIN A1C (HB1C) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON THE DIMENSION EXL INSTRUMENT DUE TO USE ERROR. THE CUSTOMER ENTERED THE SCALERS FOR HB1C USING MMOL/L UNITS INSTEAD OF % UNITS. AN INCORRECT CALIBRATION OCCURRED PRIOR TO THE EVENT DATE AND THE CUSTOMER DID NOT DETECT THE ERROR UNTIL RECALIBRATION OF HB1C ASSAY ON 06-MAY-2018. THE ORIGINAL RESULTS WITH MMOL/L SCALER UNITS WERE REPORTED TO THE PHYSICIAN. A LETTER WAS ISSUED TO ALL ORDERING PHYSICIANS INFORMING OF THE POSSIBLE BIAS IN RESULTS. A RANDOM SUBSET OF PATIENT SAMPLES WERE PROCESSED AGAIN AFTER RECALIBRATION ON THE SAME INSTRUMENT AT A LATER DATE, USING THE CORRECT SCALER % UNITS AND ON AN ALTERNATE INSTRUMENT AT AN ALTERNATE FACILITY OBTAINING THE CORRECT RESULTS. THERE WAS NO KNOWN IMPACT ON PATIENT TREATMENT OR CARE AND NO ALLEGED PATIENT HARM DUE TO THE DISCORDANT HB1C RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7642868 ↗
• MalfunctionJun 27, 2018Device Operational Issue; Device Operational Issue

  DISCORDANT HEMOGLOBIN A1C (HB1C) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON THE DIMENSION EXL INSTRUMENT DUE TO USE ERROR. THE CUSTOMER ENTERED THE SCALERS FOR HB1C USING MMOL/L UNITS INSTEAD OF % UNITS. AN INCORRECT CALIBRATION OCCURRED PRIOR TO THE EVENT DATE AND THE CUSTOMER DID NOT DETECT THE ERROR UNTIL RECALIBRATION OF HB1C ASSAY ON (B)(6) 2018. THE ORIGINAL RESULTS WITH MMOL/L SCALER UNITS WERE REPORTED TO THE PHYSICIAN. A LETTER WAS ISSUED TO ALL ORDERING PHYSICIANS INFORMING OF THE POSSIBLE BIAS IN RESULTS. A RANDOM SUBSET OF PATIENT SAMPLES WERE PROCESSED AGAIN AFTER RECALIBRATION ON THE SAME INSTRUMENT AT A LATER DATE, USING THE CORRECT SCALER % UNITS AND ON AN ALTERNATE INSTRUMENT AT AN ALTERNATE FACILITY OBTAINING THE CORRECT RESULTS. THERE WAS NO KNOWN IMPACT ON PATIENT TREATMENT OR CARE AND NO ALLEGED PATIENT HARM DUE TO THE DISCORDANT HB1C RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7642863 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102510. One submission often covers many models, so check the product and lot details in each record.

• Z-0420-2015 · Sep 30, 2014 · Terminated
  Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for