ADVIA Centaur® CA 19-9™ 10491379Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00630414574257), received between Sep 6, 2017 and Jan 17, 2025 — classified as 7 injuries, 30 malfunctions.

The most frequently reported specific device problem is “High Readings” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

7 other recalls cover devices cleared under the same FDA submission (K031393); 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.

Recalls naming this device

1. Jul 26, 2024Class IIOpen, Classified

   Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.

   Z-3103-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF DEPRESSED ADVIA CENTAUR CA 15-3 RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING WHEN USING CA 15-3 LOT 218. A CA 15-3 RESULT BELOW CUTOFF WAS OBTAINED FOR A FEMALE PATIENT WITH METASTATIC CANCER. WHEN THIS SAMPLE WAS REPEAT-TESTED FOR TROUBLESHOOTING PURPOSES, THE LOW RESULT WAS REPRODUCED. THE PATIENT WAS RE-TESTED AT A HOSPITAL, USING ABBOTT ALINITY, AND A MUCH HIGHER RESULT WAS OBTAINED. ADDITIONAL RE-TESTING USING THE SAME METHOD IN A PRIVATE LAB PRODUCED A SIMILAR ELEVATED RESULT. THE HIGHER RESULTS WERE CONSIDERED BELIEVABLE BY THE PHYSICIAN, AND THE ADVIA CENTAUR CA 15-3 RESULTS WERE IDENTIFIED AS FALSELY DEPRESSED. THERE ARE NO ALLEGATIONS OF PATIENT HARM OR ANY OTHER ADVERSE CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21185628 ↗
• MalfunctionJan 16, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ADVIA CENTAUR CA 19-9 RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND REPEAT TESTING WHEN USING CA 19-9 LOT: 543. AN INITIAL LOW CA 19-9 RESULT WAS OBTAINED FOR A FEMALE PANCREATIC CANCER PATIENT. WHEN THE SAMPLE WAS RE-TESTED, A MUCH HIGHER RESULT WAS PRODUCED; THIS ELEVATED RESULT WAS IDENTIFIED AS DISCORDANT. THE SAME SAMPLE WAS SENT TO AN EXTERNAL REFERENCE LABORATORY FOR TESTING, USING ADVIA CENTAUR CA 19-9, LOT: 541. THE REFERENCE-LAB RESULT (BELOW ASSAY CUTOFF) WAS CONSISTENT WITH EXPECTATION AND PATIENT HISTORY. THERE ARE NO ALLEGATIONS OF PATIENT HARM OR ANY OTHER ADVERSE CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170761 ↗
• MalfunctionMay 17, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ADVIA CENTAUR XPT CA 19-9 RESULTS WITH LOT# 535 FOR FOUR SAMPLES WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. THE INITIAL DISCORDANT ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE CUSTOMER REPEAT-TESTED THE SAMPLES THE SAME DAY USING AN ALTERNATE METHOD AND PRODUCED LOWER RESULTS WHICH WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). A CORRECTED REPORT WAS ISSUED BASED ON THE REPEAT TESTS. THE SAMPLES WERE ALSO TESTED ON ANOTHER ADVIA CENTAUR XPT INSTRUMENT IN ANOTHER LAB USING REAGENT LOT 533 FOR TROUBLESHOOTING PURPOSES. THESE TESTS ALSO PRODUCED LOWER RESULTS THAT THE INITIAL CA 19-9 RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19345184 ↗
• MalfunctionMay 1, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A DEPRESSED ADVIA CENTAUR CA 19-9 RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND REPEAT TESTING. CA 19-9 LOT 530 WAS IN USE AT THE TIME. A LOW CA 19-9 RESULT (WITHIN NORMAL RANGE) WAS OBTAINED FOR A 62-YEAR-OLD FEMALE PATIENT WITH PNEUMONIA. ASSAY CALIBRATION AND QUALITY CONTROL (QC) RESULTS WERE VALID AND WITHIN EXPECTED RANGES. THE RESULT WAS QUESTIONED BY THE PHYSICIAN, AND A NEW SAMPLE WAS DRAWN AND TESTED USING A DIFFERENT REAGENT LOT TWO DAYS LATER. THE NEW SAMPLE PRODUCED A MUCH HIGHER RESULT, WHICH WAS REPRODUCED IN DUPLICATE TESTING. THE EARLIER SAMPLE WAS RE-TESTED AS WELL, AND IT ALSO PRODUCED A MUCH HIGHER RESULT THAN FIRST OBTAINED. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220196 ↗
• MalfunctionJul 27, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTS THE OBSERVATION OF A DISCORDANT ELEVATED RESULT FOR A PATIENT SAMPLE WHEN RUNNING THE ADVIA CENTAUR XP ANALYZER - CA 19-9 LOT 521. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED AT ANOTHER LAB WITH AN ALTERNATE PLATFORM AND OBTAINED A NORMAL LOWER RESULT. THE CUSTOMER TOOK ANOTHER SAMPLE FROM THE SAME PATIENT AND RAN IT ON ADVIA CENTAUR XP, OBTAINING A SIMILAR HIGH RESULT. THE SECOND SAMPLE WAS REPEATED AT THE SAME LAB WITH AN ALTERNATE PLATFORM AND OBTAINED A NORMAL LOWER RESULT. THE SAME SAMPLE WAS RERUN IN THE HOSPITAL LAB AND OBTAINED A LOWER RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 19-9 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17403902 ↗
• MalfunctionJul 27, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTS THE OBSERVATION OF A DISCORDANT ELEVATED RESULT FOR A PATIENT SAMPLE WHEN RUNNING THE ADVIA CENTAUR XP ANALYZER - CA 19-9 LOT 521. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED AT ANOTHER LAB WITH AN ALTERNATE PLATFORM AND OBTAINED A NORMAL LOWER RESULT. THE CUSTOMER TOOK ANOTHER SAMPLE FROM THE SAME PATIENT AND RAN IT ON ADVIA CENTAUR XP, OBTAINING A SIMILAR HIGH RESULT. THE SECOND SAMPLE WAS REPEATED AT THE SAME LAB WITH AN ALTERNATE PLATFORM AND OBTAINED A NORMAL LOWER RESULT. THE SAME SAMPLE WAS RERUN IN THE HOSPITAL LAB AND OBTAINED A LOWER RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 19-9 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17403896 ↗
• MalfunctionJun 19, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED A DISCORDANT DEPRESSED CA 19-9 RESULT FOR A MALE PATIENT SAMPLE ON ADVIA CENTAUR CP COMPARED TO AN ALTERNATE METHOD. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED IN A DIFFERENT LAB ON AN UNKNOWN METHOD, AND THE RESULT WAS HIGHER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA19-9 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17151476 ↗
• MalfunctionApr 19, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF DEPRESSED ATELLICA IM 1600 CA 19-9 RESULTS FOR THREE PATIENTS, WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. THE CUSTOMER EXPERIENCED CA 19-9 ASSAY CALIBRATION FAILURE ON (B)(6) 2022. RESULTS PRODUCED SINCE LAST SUCCESSFUL CALIBRATION WERE REVIEWED, AND IT WAS FOUND THAT SOME PATIENT RESULTS PRODUCED ON (B)(6) 2022 WERE DISCORDANT RELATIVE TO REPEAT TESTING. QUALITY CONTROL (QC) RESULTS WERE OUT OF RANGE ON THIS DAY, AS WELL. THREE PATIENT RESULTS WERE IDENTIFIED AS DISCORDANT, WITH DEPRESSED RESULTS OBSERVED ON (B)(6) 2022, AND HIGHER RESULTS (>30% DIFFERENCE) OBTAINED WHEN THE SAME SAMPLES WERE RE-TESTED USING FRESH REAGENT AND NEW CALIBRATION ON (B)(6) 2022. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAY IN DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14149001 ↗
• MalfunctionSep 24, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER OBSERVED DISCORDANT ADVIA CENTAUR XPT CA19-9 RESULTS WITH ONE PATIENT SAMPLE UPON DILUTION. THE NON-DILUTED RESULT AND THE MANUALLY DILUTED RESULT WERE ABOVE THE ASSAY MEASURING RANGE, WHILE THE AUTO-DILUTED RESULT WAS WITHIN THE ASSAY MEASURING RANGE. NONE OF THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE CUSTOMER IS WAITING FOR A NEW SAMPLE DRAW FROM THE PATIENT FOR RETESTING. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS PRESCRIBED, DELAYED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA19-9 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10583973 ↗
• MalfunctionFeb 27, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A FALSELY ELEVATED ADVIA CENTAUR XP CA 19-9 RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE LABORATORY RAN THIS PATIENT SAMPLE THROUGH HETEROPHILIC ANTIBODY BLOCKING TUBES AND THE RESULT WAS LOWER. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9764200 ↗
• MalfunctionFeb 27, 2020No Apparent Adverse Event; No Apparent Adverse Event

  FALSELY ELEVATED ADVIA CENTAUR XP CA 19-9 RESULTS WERE OBTAINED ON THREE DIFFERENT SAMPLES FOR THE SAME PATIENT. THE RESULTS OF THE FIRST TWO SAMPLES WERE NOT QUESTIONED BY THE LABORATORY, BUT THE PATIENT WENT TO ANOTHER LABORATORY AND ASKED FOR THE SAME TEST. THE RESULT WAS IN THE NORMAL RANGE ON AN ALTERNATE METHOD. THEN, THE PATIENT REQUESTED A THIRD SAMPLE BE TESTED AND THE ADVIA CENTAUR XP CA 19-9 RESULT WAS ELEVATED. THE SAMPLE WAS REPEATED ON ANOTHER ADVIA CENTAUR XP SYSTEM AND THE RESULT WAS ELEVATED. THE PATIENT SAMPLE WAS SENT TO TWO OTHER LABORATORIES AND TESTED ON AN ALTERNATE METHOD AND THE ATELLICA SOLUTION. THE RESULTS WERE LOWER. THERE IS NO INDICATION OF A CANCER DIAGNOSIS OR OTHER SERIOUS ILLNESS WITH THIS PATIENT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9764197 ↗
• MalfunctionFeb 27, 2020No Apparent Adverse Event; No Apparent Adverse Event

  FALSELY ELEVATED ADVIA CENTAUR XP CA 19-9 RESULTS WERE OBTAINED ON THREE DIFFERENT SAMPLES FOR THE SAME PATIENT. THE RESULTS OF THE FIRST TWO SAMPLES WERE NOT QUESTIONED BY THE LABORATORY, BUT THE PATIENT WENT TO ANOTHER LABORATORY AND ASKED FOR THE SAME TEST. THE RESULT WAS IN THE NORMAL RANGE ON AN ALTERNATE METHOD. THEN, THE PATIENT REQUESTED A THIRD SAMPLE BE TESTED AND THE ADVIA CENTAUR XP CA 19-9 RESULT WAS ELEVATED. THE SAMPLE WAS REPEATED ON ANOTHER ADVIA CENTAUR XP SYSTEM AND THE RESULT WAS ELEVATED. THE PATIENT SAMPLE WAS SENT TO TWO OTHER LABORATORIES AND TESTED ON AN ALTERNATE METHOD AND THE ATELLICA SOLUTION. THE RESULTS WERE LOWER. THERE IS NO INDICATION OF A CANCER DIAGNOSIS OR OTHER SERIOUS ILLNESS WITH THIS PATIENT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9764182 ↗
• MalfunctionFeb 27, 2020No Apparent Adverse Event; No Apparent Adverse Event

  FALSELY ELEVATED ADVIA CENTAUR XP CA 19-9 RESULTS WERE OBTAINED ON THREE DIFFERENT SAMPLES FOR THE SAME PATIENT. THE RESULTS OF THE FIRST TWO SAMPLES WERE NOT QUESTIONED BY THE LABORATORY, BUT THE PATIENT WENT TO ANOTHER LABORATORY AND ASKED FOR THE SAME TEST. THE RESULT WAS IN THE NORMAL RANGE ON AN ALTERNATE METHOD. THEN, THE PATIENT REQUESTED A THIRD SAMPLE BE TESTED AND THE ADVIA CENTAUR XP CA 19-9 RESULT WAS ELEVATED. THE SAMPLE WAS REPEATED ON ANOTHER ADVIA CENTAUR XP SYSTEM AND THE RESULT WAS ELEVATED. THE PATIENT SAMPLE WAS SENT TO TWO OTHER LABORATORIES AND TESTED ON AN ALTERNATE METHOD AND THE ATELLICA SOLUTION. THE RESULTS WERE LOWER. THERE IS NO INDICATION OF A CANCER DIAGNOSIS OR OTHER SERIOUS ILLNESS WITH THIS PATIENT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9764179 ↗
• MalfunctionFeb 27, 2020No Apparent Adverse Event; No Apparent Adverse Event

  FALSELY ELEVATED ADVIA CENTAUR XP CA 19-9 RESULTS WERE OBTAINED ON THREE DIFFERENT SAMPLES FOR THE SAME PATIENT. THE RESULTS OF THE FIRST TWO SAMPLES WERE NOT QUESTIONED BY THE LABORATORY, BUT THE PATIENT WENT TO ANOTHER LABORATORY AND ASKED FOR THE SAME TEST. THE RESULT WAS IN THE NORMAL RANGE ON AN ALTERNATE METHOD. THEN, THE PATIENT REQUESTED A THIRD SAMPLE BE TESTED AND THE ADVIA CENTAUR XP CA 19-9 RESULT WAS ELEVATED. THE SAMPLE WAS REPEATED ON ANOTHER ADVIA CENTAUR XP SYSTEM AND THE RESULT WAS ELEVATED. THE PATIENT SAMPLE WAS SENT TO TWO OTHER LABORATORIES AND TESTED ON AN ALTERNATE METHOD AND THE ATELLICA SOLUTION. THE RESULTS WERE LOWER. THERE IS NO INDICATION OF A CANCER DIAGNOSIS OR OTHER SERIOUS ILLNESS WITH THIS PATIENT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9764174 ↗
• MalfunctionJan 21, 2020High Test Results; No Apparent Adverse Event; High Test Results; No Apparent Adverse Event

  TWO DISCORDANT HIGH RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE WITH THE ADVIA CENTAUR XPT CA19-9 IMMUNOASSAY. THE PATIENT SAMPLE WAS TESTED ON TWO ADVIA CENTAUR XP SYSTEMS AND SIMILAR HIGH RESULTS WERE OBTAINED BETWEEN THE SYSTEMS. THE RESULTS WERE REPORTED TO PHYSICIAN AND QUESTIONED. A NEW SAMPLE FROM THE SAME PATIENT WAS OBTAINED AT A LATER DATE AND TESTED WITH ATELLICA IM CA19-9 IMMUNOASSAY ON TWO SYSTEMS. LOWER RESULTS WERE OBTAINED ON BOTH SYSTEMS. A CORRECTED REPORT WAS ISSUED WITH THE LOWER RESULTS. QUALITY CONTROL WAS WITHIN SPECIFICATION FOR ALL SYSTEMS USED FOR TESTING. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HIGH CA19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9612375 ↗
• MalfunctionJan 21, 2020High Test Results; No Apparent Adverse Event; High Test Results; No Apparent Adverse Event

  TWO DISCORDANT HIGH RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE WITH THE ADVIA CENTAUR XPT CA19-9 IMMUNOASSAY. THE PATIENT SAMPLE WAS TESTED ON TWO ADVIA CENTAUR XP SYSTEMS AND SIMILAR HIGH RESULTS WERE OBTAINED BETWEEN THE SYSTEMS. THE RESULTS WERE REPORTED TO PHYSICIAN AND QUESTIONED. A NEW SAMPLE FROM THE SAME PATIENT WAS OBTAINED AT A LATER DATE AND TESTED WITH ATELLICA IM CA19-9 IMMUNOASSAY ON TWO SYSTEMS. LOWER RESULTS WERE OBTAINED ON BOTH SYSTEMS. A CORRECTED REPORT WAS ISSUED WITH THE LOWER RESULTS. QUALITY CONTROL WAS WITHIN SPECIFICATION FOR ALL SYSTEMS USED FOR TESTING. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HIGH CA19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9612373 ↗
• MalfunctionNov 20, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT HIGH ADVIA CENTAUR XPT CA 19-9 RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED, AND THE RESULT WAS HIGH. THE HIGH RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT SAMPLE WAS ALSO RUN ON THE ADVIA CENTAUR XP AND ATELLICA IM PLATFORMS. THE RESULTS WERE HIGH. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULTS WERE LOWER. A CORRECTED REPORT WAS ISSUED. AN ENDOSCOPY WAS PERFORMED. THE RESULTS OF THE ENDOSCOPY WERE NOT PROVIDED. OTHER CLINICAL DIAGNOSTIC TESTS PERFORMED, AND THE RESULT WAS NONSPECIFIC GASTRITIS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9347276 ↗
• MalfunctionNov 20, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT HIGH ADVIA CENTAUR XPT CA 19-9 RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED, AND THE RESULT WAS HIGH. THE HIGH RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT SAMPLE WAS ALSO RUN ON THE ADVIA CENTAUR XP AND ATELLICA IM PLATFORMS. THE RESULTS WERE HIGH. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULTS WERE LOWER. A CORRECTED REPORT WAS ISSUED. AN ENDOSCOPY WAS PERFORMED. THE RESULTS OF THE ENDOSCOPY WERE NOT PROVIDED. OTHER CLINICAL DIAGNOSTIC TESTS PERFORMED, AND THE RESULT WAS NONSPECIFIC GASTRITIS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9347274 ↗
• MalfunctionNov 13, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT HIGH ADVIA CENTAUR CP CA 19-9 RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED, AND THE RESULT WAS HIGH. THE HIGH RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS LOWER. A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9314673 ↗
• MalfunctionNov 13, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT HIGH ADVIA CENTAUR CP CA 19-9 RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED, AND THE RESULT WAS HIGH. THE HIGH RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS LOWER. A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9314672 ↗
• InjurySep 13, 2019Off-Label Use; High Readings; No Apparent Adverse Event; Off-Label Use; High Readings; No Apparent Adverse Event

  ADVIA CENTAUR XP CA 19-9 DISCORDANT HIGH RESULTS WERE OBTAINED FOR SEVEN SAMPLES FROM THE SAME PATIENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. REPEAT TESTING WAS PERFORMED USING DIFFERENT SAMPLES ON TWO ALTERNATE METHODS AND THE RESULTS WERE NEGATIVE. THE CUSTOMER DOES NOT KNOW WHICH RESULT IS CORRECT. THE PATIENT WAS IN THE INTENSIVE CARE UNIT. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9038856 ↗
• InjurySep 13, 2019Off-Label Use; High Readings; No Apparent Adverse Event; Off-Label Use; High Readings; No Apparent Adverse Event

  ADVIA CENTAUR XP CA 19-9 DISCORDANT HIGH RESULTS WERE OBTAINED FOR SEVEN SAMPLES FROM THE SAME PATIENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. REPEAT TESTING WAS PERFORMED USING DIFFERENT SAMPLES ON TWO ALTERNATE METHODS AND THE RESULTS WERE NEGATIVE. THE CUSTOMER DOES NOT KNOW WHICH RESULT IS CORRECT. THE PATIENT WAS IN THE INTENSIVE CARE UNIT. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9038831 ↗
• InjurySep 13, 2019Off-Label Use; High Readings; No Apparent Adverse Event; Off-Label Use; High Readings; No Apparent Adverse Event

  ADVIA CENTAUR XP CA 19-9 DISCORDANT HIGH RESULTS WERE OBTAINED FOR SEVEN SAMPLES FROM THE SAME PATIENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. REPEAT TESTING WAS PERFORMED USING DIFFERENT SAMPLES ON TWO ALTERNATE METHODS AND THE RESULTS WERE NEGATIVE. THE CUSTOMER DOES NOT KNOW WHICH RESULT IS CORRECT. THE PATIENT WAS IN THE INTENSIVE CARE UNIT. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9038706 ↗
• InjurySep 13, 2019Off-Label Use; High Readings; No Apparent Adverse Event; Off-Label Use; High Readings; No Apparent Adverse Event

  ADVIA CENTAUR XP CA 19-9 DISCORDANT HIGH RESULTS WERE OBTAINED FOR SEVEN SAMPLES FROM THE SAME PATIENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. REPEAT TESTING WAS PERFORMED USING DIFFERENT SAMPLES ON TWO ALTERNATE METHODS AND THE RESULTS WERE NEGATIVE. THE CUSTOMER DOES NOT KNOW WHICH RESULT IS CORRECT. THE PATIENT WAS IN THE INTENSIVE CARE UNIT. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9038655 ↗
• InjurySep 13, 2019Off-Label Use; High Readings; No Apparent Adverse Event; Off-Label Use; High Readings; No Apparent Adverse Event

  ADVIA CENTAUR XP CA 19-9 DISCORDANT HIGH RESULTS WERE OBTAINED FOR SEVEN SAMPLES FROM THE SAME PATIENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. REPEAT TESTING WAS PERFORMED USING DIFFERENT SAMPLES ON TWO ALTERNATE METHODS AND THE RESULTS WERE NEGATIVE. THE CUSTOMER DOES NOT KNOW WHICH RESULT IS CORRECT. THE PATIENT WAS IN THE INTENSIVE CARE UNIT. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9038604 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031393. One submission often covers many models, so check the product and lot details in each record.

• Z-3101-2024 · Jul 26, 2024 · Open, Classified
  Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM
• Z-3104-2024 · Jul 26, 2024 · Open, Classified
  ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica I
• Z-3102-2024 · Jul 26, 2024 · Open, Classified
  Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atelli
• Z-3100-2024 · Jul 26, 2024 · Open, Classified
  Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM A
• Z-0612-2017 · Oct 19, 2016 · Terminated
  ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491
• Z-0613-2017 · Oct 19, 2016 · Terminated
  ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491
• Z-0508-2013 · Nov 14, 2012 · Terminated
  Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use The ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measureme