Dimension® Flex® reagent cartridge LIPL 10460277Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00842768025532), received between Apr 12, 2018 and Jan 29, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 reports).

1 FDA recall record name this device's identifier.

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 14, 2017Class IITerminated

   Calibration failure - confirmed a positive bias with LIPL lot FB8109 when compared to other Dimension LIPL lots. Lot FB8109 is not meeting Siemens internal specifications for lot-to-lot limits.

   Z-1796-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionJan 29, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED LIPASE (LIPL) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION XPAND PLUS WITH HM SYSTEM. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. A NEW SAMPLE WAS DRAWN THE SAME DAY AND PROCESSED ON A NON-SIEMENS SYSTEM BY AN ALTERNATE METHODOLOGY. AN ELEVATED RESULT, CONSIDERED CORRECT, WAS OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED LIPASE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11254444 ↗
• MalfunctionJun 24, 2020High Test Results; High Test Results

  AN ELEVATED LIPASE (LIPL) RESULT, QUESTIONED AS DISCORDANT, WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS HOSPITALIZED. A NEW SAMPLE DRAWN WITHIN 24 HOURS WAS PROCESSED ON AN ALTERNATE NON-SIEMENS SYSTEM AND A LOWER RESULT, WITHIN THE NORMAL RANGE FOR THAT METHODOLOGY, WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED LIPASE RESULT OR THE HOSPITALIZATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10192461 ↗
• MalfunctionApr 24, 2020Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED LIPASE (LIPL) RESULT WAS OBTAINED ON A DILUTED PATIENT SAMPLE ON A DIMENSION EXL SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE DIMENSION EXL AND A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED LIPASE RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9996264 ↗
• MalfunctionJun 4, 2018High Test Results; High Test Results

  A DISCORDANT ELEVATED LIPASE (LIPL) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL 200 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE PATIENT HAD A NEW SAMPLE DRAWN AT A LATER TIME ON THE SAME DATE AND A LOWER RESULT WAS OBTAINED AND REPORTED. NO CORRECTED REPORT WAS ISSUED. THE PATIENT WAS ADMITTED BASED ON THE SYMPTOMS AND LABORATORY RESULT OF THE ELEVATED LIPASE FOR EVALUATION AND FLUIDS (SUSPECTED PANCREATITIS). THE PATIENT WAS GIVEN NACL IV FLUIDS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED LIPL RESULT OR TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7565063 ↗
• MalfunctionApr 12, 2018High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED LIPASE (LIPL) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION RXL MAX HM SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. ADDITIONAL SAMPLES WERE COLLECTED AND RUN ON THE SAME PATIENT LATER IN THE DAY AND LOWER RESULTS WERE OBTAINED. THE PATIENT WAS HOSPITALIZED FOR SUSPECTED PANCREATITIS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED LIPL RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7427112 ↗
• MalfunctionApr 12, 2018High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED LIPASE (LIPL) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION RXL MAX HM SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS TESTED ON THE SAME INSTRUMENT AT A LATER DATE AND AN ELEVATED RESULT WAS OBTAINED. THE PATIENT WAS HOSPITALIZED FOR SUSPECTED PANCREATITIS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED LIPL RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7427110 ↗