ADVIA Chemistry UCFP 11319151Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00630414279176), received between Jun 30, 2023 and Oct 22, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (10 reports).

2 FDA recall records name this device's identifier, 2 still open.

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. Jul 29, 2024Class IIOpen, Classified

   The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.

   Z-3064-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jul 25, 2023Class IIOpen, Classified

   There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be observed when the assay is processed after the UCFP test on ADVIA Chemistry systems.

   Z-2451-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT ON A PATIENT SAMPLE ON AN ADVIA CHEMISTRY XPT SYSTEM. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPROCESSED ON THE ORIGINAL SYSTEM AND AN ERROR MESSAGE WAS OBTAINED. ANOTHER RANDOM URINE SAMPLE FROM THE SAME PATIENT WAS TESTED ON THE ORIGINAL SYSTEM AND A LOWER RESULT WAS OBTAINED, WHICH WAS CONSIDERED ERRONEOUS. THEN, THE CUSTOMER PROCESSED PATIENT'S URINE DIPSTICK PROTEIN ASSAY ON SYSMEX UC-3500 INSTRUMENT, WHICH RECOVERED POSITIVE AND CONSIDERED CORRECT. LATER, THE PATIENT WENT TO AN ALTERNATE FACILITY TO TEST UCFP WITH OTHER PLATFORM, HOWEVER, THE SAMPLE DATA WAS NOT PROVIDED TO SIEMENS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED UCFP RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20503955 ↗
• MalfunctionOct 2, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED ONE (1) ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) PATIENT SAMPLE RESULT WAS OBTAINED ON AN ADVIA® 2400 CLINICAL CHEMISTRY SYSTEM. THE ERRONEOUSLY DEPRESSED PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ADVIA® 2400 CLINICAL CHEMISTRY SYSTEM. A HIGHER 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 DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20356153 ↗
• MalfunctionAug 27, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) PATIENT SAMPLE RESULTS WERE OBTAINED ON AN ADVIA CHEMISTRY XPT SYSTEM. THE ERRONEOUSLY DEPRESSED SAMPLE RESULT WAS REPORTED TO THE PHYSICIAN AND WAS NOT QUESTIONED. A NEW SAMPLE WAS PROCESSED ON AN ALTERNATE SYSTEM, AN ATELLICA CH 930 ANALYZER. A HIGHER 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 DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20081861 ↗
• MalfunctionAug 27, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) PATIENT SAMPLE RESULTS WERE OBTAINED ON AN ADVIA CHEMISTRY XPT SYSTEM. THE ERRONEOUSLY DEPRESSED SAMPLE RESULT WAS REPORTED TO THE PHYSICIAN AND WAS NOT QUESTIONED. A NEW SAMPLE WAS PROCESSED ON AN ALTERNATE SYSTEM, AN ATELLICA CH (B)(6) ANALYZER. A HIGHER 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 DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20081285 ↗
• MalfunctionAug 27, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) PATIENT SAMPLE RESULTS WERE OBTAINED ON AN ADVIA CHEMISTRY XPT SYSTEM. THE ERRONEOUSLY DEPRESSED SAMPLE RESULT WAS REPORTED TO THE PHYSICIAN AND WAS NOT QUESTIONED. A NEW SAMPLE WAS PROCESSED ON AN ALTERNATE SYSTEM, AN ATELLICA CH 930 ANALYZER. A HIGHER 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 DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20081276 ↗
• MalfunctionAug 27, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) PATIENT SAMPLE RESULTS WERE OBTAINED ON AN ADVIA CHEMISTRY XPT SYSTEM. THE ERRONEOUSLY DEPRESSED SAMPLE RESULT WAS REPORTED TO THE PHYSICIAN AND WAS NOT QUESTIONED. A NEW SAMPLE WAS PROCESSED ON AN ALTERNATE SYSTEM, AN ATELLICA CH 930 ANALYZER. A HIGHER 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 DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20081099 ↗
• MalfunctionJun 6, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) PATIENT SAMPLE RESULT ON AN ADVIA® 2400 CLINICAL CHEMISTRY SYSTEM. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN AND WAS NOT QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE SAME ADVIA® 2400 CLINICAL CHEMISTRY SYSTEM. THE REPROCESSED RESULT OBTAINED WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475878 ↗
• MalfunctionJun 6, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS ON FOUR (4) PATIENT SAMPLES ON AN ADVIA® 2400 CLINICAL CHEMISTRY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON THE SAME ADVIA® 2400 CLINICAL CHEMISTRY SYSTEM. THE REPROCESSED RESULTS OBTAINED WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475875 ↗
• MalfunctionJun 6, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS ON TWO (2) PATIENT SAMPLES ON AN ADVIA® 2400 CLINICAL CHEMISTRY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON THE SAME ADVIA® 2400 CLINICAL CHEMISTRY SYSTEM. THE REPROCESSED RESULTS OBTAINED WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475867 ↗
• MalfunctionJun 30, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT ON A PATIENT SAMPLE ON ADVIA CHEMISTRY XPT. THE INITIAL ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE INITIAL ADVIA CHEMISTRY XPT INSTRUMENT AND OBTAINED THE RESULT SAME AS THE INITIAL RESULT. THE CUSTOMER REPEATED THE SAMPLE ON AN ALTERNATE METHOD FOR ALBUMIN. THE REPEAT RESULT WAS HIGHER THAN THE INITIAL RESULT. THE REPEAT RESULT WAS CONSIDERED AS CORRECT BY THE PHYSICIAN(S) AS URINE ROUTINE TEST FOR THIS SAMPLE WAS POSITIVE FOR URINE PROTEIN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO FALSELY DEPRESSED URINE PROTEIN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237265 ↗