ADVIA Centaur CA 19-9Recalls & reported problems across all models

We found 2 models of ADVIA Centaur CA 19-9 by Siemens Healthcare Diagnostics Inc. in the FDA's device registry (GUDID). Together they are named in 124 adverse event reports in the FDA's MAUDE database, received between Sep 6, 2017 and Jan 17, 2025 — classified as 7 injuries, 117 malfunctions.

The most frequently reported specific device problem is “High Test Results” (68 reports).

2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

ADVIA Centaur CA 19-9 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 26, 2024Open, 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-3104-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jul 26, 2024Open, 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 ADVIA Centaur CA 19-9 problems

ADVIA Centaur CA 19-9 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ADVIA Centaur® CA 19-9™ 10491244

  SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
  1 recall87 reports
• ADVIA Centaur® CA 19-9™ 10491379

  SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
  1 recall37 reports

Recent ADVIA Centaur CA 19-9 adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionDec 9, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ADVIA CENTAUR XP CA 19-9 RESULT FOR A PATIENT SAMPLE WHICH WAS DISCORDANT RELATIVE TO ALTERNATE METHOD TESTING WHEN USING REAGENT LOT 539. AN INITIAL ELEVATED ADVIA CENTAUR CA 19-9 RESULT WAS OBTAINED AND REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS THEN REPEATED USING AN ALTERNATE TESTING METHOD AND THE RESULT OBTAINED WAS MUCH LOWER. THIS RESULT WAS CONSIDERED CORRECT AS IT MATCHED THE CLINICAL PICTURE OF THE PATIENT AND A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN(S). 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 20876955 ↗
• MalfunctionSep 19, 2024High Test Results; High Test Results

  THE CUSTOMER CONTACTED SIEMENS TO REPORT AN OBSERVATION OF A DISCORDANT (ELEVATED) ADVIA CENTAUR XP CA 19-9, LOT 535 RESULT ON A SAMPLE FROM A PATIENT WITH NO CLINICAL HISTORY OF CANCER. THE PATIENT SAMPLE WAS INITIALLY TESTED WITH ADVIA CENTAUR XP CA 19-9, LOT 535 AND RESULTED ABOVE THE EXPECTED NORMAL VALUE RANGE (>37 U/ML). THE RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. THE PATIENT WAS TESTED FOR CA19-9 AT ANOTHER HOSPITAL AND THE RESULT WAS WITHIN NORMAL RANGE. THERE ARE NO REPORTS ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20254372 ↗
• MalfunctionSep 18, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS ADVIA CENTAUR XPT CA19-9 LOT 535 DISCORDANT (ELEVATED) RESULT RELATIVE TO ALTERNATE METHOD TESTING. THE ALTERNATE METHOD TESTING IS CONSIDERED CORRECT. IT IS UNKNOWN IF THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THESE OBSERVATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20252011 ↗
• MalfunctionAug 8, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED OBSERVATION OF AN ELEVATED ADVIA CENTAUR CA 19-9 RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING CA 19-9 LOT 535. AN INITIAL ELEVATED RESULT WAS OBTAINED USING CA 19-9 LOT 535 FOR A 55-YEAR-OLD FEMALE PATIENT WITH POST-OPERATIVE RECTAL CANCER. THIS RESULT WAS QUESTIONED BY THE PHYSICIAN. WHEN THE SAMPLE WAS RE-TESTED USING CA 19-9 LOT 537, A MUCH LOWER RESULT (BELOW REFERENCE THRESHOLD) WAS PRODUCED. THE TEST WAS REPEATED USING AN ALTERNATE METHOD, AND A LOW RESULT (BELOW REFERENCE RANGE) WAS OBTAINED; THIS RESULT WAS ACCEPTED AS CORRECT BY THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19938332 ↗
• MalfunctionJul 3, 2024High Test Results; High Test Results

  THE CUSTOMER OBTAINED REPEAT ELEVATED RESULTS ON A PATIENT SAMPLE THAT WAS TESTED WITH CA 19-9, REAGENT LOT 535, ON AN ADVIA CENTAUR CP INSTRUMENT. THE CUSTOMER TESTED THE SAME SAMPLE WITH AN ALTERNATE TEST METHOD (ROCHE) AND RESULT WAS ALSO ELEVATED. THESE ELEVATED RESULTS WERE DISCORDANT RELATIVE TO A LOWER RESULT OBTAINED WHEN RETESTING THE SAMPLE WITH A DIFFERENT CA 19-9 REAGENT LOT (537). THE LOWER RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THE ELEVATED DISCORDANT RESULTS WERE NOT REPORTED. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19665778 ↗
• MalfunctionJun 17, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ADVIA CENTAUR CA 19-9 RESULTS FOR TWO PATIENTS WHEN USING LOT 535 WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING REAGENT LOT 537 AND AN ALTERNATE METHOD. INITIAL ELEVATED ADVIA CENTAUR CA 19-9 RESULTS (ABOVE REFERENCE RANGE) WERE OBTAINED FOR TWO PATIENT SAMPLES. THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE PATIENT 1 SAMPLE WAS REPEATED ON THE SAME ADVIA CENTAUR INSTRUMENT USING REAGENT LOT 537 AND THE PATIENT 2 SAMPLE WAS REPEATED USING AN ALTERNATE METHOD PRODUCING LOWER RESULTS. THE LOWER RESULTS WERE CONSIDERED CORRECT, AS THEY WERE IN AGREEMENT WITH THE CLINICAL PICTURE, AND CORRECTED REPORTS WERE ISSUED BASED ON THE REPEAT TESTING. IT IS UNKNOWN WHETHER THE AFFECTED PATIENTS HAVE BEEN DIAGNOSED WITH CANCER. 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 19554955 ↗
• MalfunctionJun 14, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ADVIA CENTAUR CA 19-9 RESULTS WITH LOT 537 WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING ON AN ALTERNATE METHOD. INITIAL ELEVATED RESULTS WERE OBTAINED FOR FOUR (4) PATIENT SAMPLES. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE THEN RETESTED USING AN ALTERNATE METHOD AND PRODUCED LOWER RESULTS. THE LOWER RESULTS WERE CONSIDERED CORRECT AS THEY AGREED WITH THE CLINICAL CONDITION OF THE PATIENTS AND REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN WHETHER THE AFFECTED PATIENTS HAVE BEEN DIAGNOSED WITH CANCER. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT RESULTING FROM THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19539208 ↗
• MalfunctionJun 11, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED HIGH ADVIA CENTAUR CA 19-9 (CA19-9) LOT 535 RESULTS ON SAMPLES FROM PATIENT THAT WERE PREVIOUSLY CONSIDERED NORMAL. THE INITIAL RESULTS WERE REPORTED AND QUESTIONED BY THE PHYSICIAN(S). SAMPLES WERE SENT TO THE CUSTOMER LAB HEADQUARTERS FOR VERIFICATION TESTING USING ATELLICA IM CA19-9. THE ATELLICA IM RESULTS WERE LOWER AND IN AGREEMENT WITH HISTORICAL PATIENT RESULTS. CORRECTED REPORTS WERE ISSUED. THERE ARE NO REPORTS THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509682 ↗
• MalfunctionJun 11, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED HIGH ADVIA CENTAUR CA 19-9 (CA19-9) LOT 535 RESULTS ON SAMPLES FROM PATIENT THAT WERE PREVIOUSLY CONSIDERED NORMAL. THE INITIAL RESULTS WERE REPORTED AND QUESTIONED BY THE PHYSICIAN(S). SAMPLES WERE SENT TO THE CUSTOMER LAB HEADQUARTERS FOR VERIFICATION TESTING USING ATELLICA IM CA19-9. THE ATELLICA IM RESULTS WERE LOWER AND IN AGREEMENT WITH HISTORICAL PATIENT RESULTS. CORRECTED REPORTS WERE ISSUED. THERE ARE NO REPORTS THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509664 ↗
• MalfunctionJun 7, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ADVIA CENTAUR CA 19-9 RESULTS WHEN USING LOT 535 WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING USING REAGENT LOT 537. INITIAL ELEVATED RESULTS WERE OBTAINED FOR 36 PATIENT SAMPLES WHEN TESTED USING CA 19-9 LOT 535. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE SAME SAMPLES WERE THEN REPEAT TESTED USING LOT 537 AND PRODUCED LOWER RESULTS. THE LOWER RESULTS WERE CONSIDERED CORRECT AS THEY AGREED WITH THE CLINICAL CONDITION OF THE PATIENTS AND WERE ISSUED ON THE CORRECTED REPORTS TO THE PHYSICIAN(S). IT IS UNKNOWN WHETHER THE AFFECTED PATIENTS HAVE BEEN DIAGNOSED WITH CANCER. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT RESULTING FROM THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19481632 ↗
• MalfunctionJun 5, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ADVIA CENTAUR CA 19-9 RESULTS WHEN USING LOT 535 WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING USING REAGENT LOT 537. INITIAL ELEVATED ADVIA CENTAUR CA 19-9 RESULTS WERE OBSERVED FOR 67 PATIENTS WHEN TESTED WITH CA 19-9 LOT 535. THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPEATED USING REAGENT LOT 537, PRODUCING LOWER RESULTS. THE LOWER RESULTS WERE CONSIDERED CORRECT AS THEY WERE IN AGREEMENT WITH THE CLINICAL PICTURE, AND CORRECTED REPORTS WERE ISSUED BASED ON THE REPEAT TESTING. IT IS UNKNOWN WHETHER THE AFFECTED PATIENTS HAVE BEEN DIAGNOSED WITH CANCER. 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 19468200 ↗
• MalfunctionJun 4, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ADVIA CENTAUR CA 19-9 RESULTS WHEN USING LOT 535 WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING USING ANOTHER REAGENT LOT 537. INITIAL ELEVATED ADVIA CENTAUR CA 19-9 RESULTS (ABOVE REFERENCE RANGE) WERE OBTAINED FOR 24 PATIENT SAMPLES. THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED USING REAGENT LOT 537, PRODUCING LOWER RESULTS. THE LOWER RESULTS WERE CONSIDERED CORRECT, AS THEY WERE IN AGREEMENT WITH THE CLINICAL PICTURE, AND CORRECTED REPORTS WERE ISSUED BASED ON THE REPEAT TESTING. IT IS UNKNOWN WHETHER THE AFFECTED PATIENTS HAVE BEEN DIAGNOSED WITH CANCER. 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 19461750 ↗
• MalfunctionMay 17, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ADVIA CENTAUR CA 19-9 (CA 19-9) RESULTS FROM LOT 535 WHICH WERE DISCORDANT RELATIVE TO LOT 534 AND PREVIOUS TEST RESULTS. ELEVATED ADVIA CENTAUR CA 19-9 RESULTS WERE OBTAINED FOR 8 PATIENTS. UPON REVIEW OF PATIENT TEST HISTORY, THE CUSTOMER REPEAT-TESTED THE SAMPLES USING CA 19-9 LOT 534. THE RESULTS OBTAINED USING LOT 534 WERE LOWER AND REPORTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT RESULTING FROM THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19347105 ↗

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