ADVIA Centaur® CA 19-9™ 10491244Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00630414574028), received between Aug 31, 2018 and Dec 9, 2024 — classified as 87 malfunctions.

The most frequently reported specific device problem is “High Test Results” (62 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-3104-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMay 17, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ADVIA CENTAUR CA 19-9(CA 19-9) RESULTS WITH LOT 535 WHICH WERE DISCORDANT RELATIVE TO LOT 534 AND PREVIOUS TEST RESULTS. ELEVATED ADVIA CENTAUR CA 19-9 RESULTS WERE OBTAINED FOR 14 PATIENT SAMPLES. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN, WHO DID NOT QUESTION THE RESULTS. THE CUSTOMER REPEATED THE SAMPLES USING CA 19-9 LOT 534 UPON REVIEW OF PATIENT¿S TEST HISTORY. THE RESULTS OBTAINED WERE LOWER AND CONSIDERED CORRECT. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). 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 19347060 ↗
• MalfunctionMay 17, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED CA 19-9 RESULTS WITH LOT 535 WHICH ARE DISCORDANT RELATIVE TO REPEAT TESTING WITH LOT 530. THE CUSTOMER IDENTIFIED A POSITIVE SHIFT IN CA 19-9 RESULTS AFTER SWITCHING TO A NEW LOT OF REAGENT, AND RE-TESTED PATIENT SAMPLES USING LOT 530 WHICH HAD BEEN INITIALLY TESTED USING LOT 535. LOWER RESULTS OBTAINED USING LOT 530 WERE CONSIDERED CORRECT AND REPORTED TO PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED CA 19-9 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19340705 ↗
• MalfunctionMay 17, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED CA 19-9 RESULTS WITH LOT 535 WHICH ARE DISCORDANT RELATIVE TO REPEAT TESTING WITH LOT 530. THE CUSTOMER IDENTIFIED A POSITIVE SHIFT IN CA 19-9 RESULTS AFTER SWITCHING TO A NEW LOT OF REAGENT, AND RE-TESTED PATIENT SAMPLES USING LOT 530 WHICH HAD BEEN INITIALLY TESTED USING LOT 535. LOWER RESULTS OBTAINED USING LOT 530 WERE CONSIDERED CORRECT AND REPORTED TO PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED CA 19-9 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19340690 ↗
• MalfunctionMay 17, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED CA 19-9 RESULTS WITH LOT 535 WHICH ARE DISCORDANT RELATIVE TO REPEAT TESTING WITH LOT 530. THE CUSTOMER IDENTIFIED A POSITIVE SHIFT IN CA 19-9 RESULTS AFTER SWITCHING TO A NEW LOT OF REAGENT, AND RE-TESTED PATIENT SAMPLES USING LOT 530 WHICH HAD BEEN INITIALLY TESTED USING LOT 535. LOWER RESULTS OBTAINED USING LOT 530 WERE CONSIDERED CORRECT AND REPORTED TO PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED CA 19-9 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19340668 ↗
• MalfunctionMay 17, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED CA 19-9 RESULTS WITH LOT 535 WHICH ARE DISCORDANT RELATIVE TO REPEAT TESTING WITH LOT 530. THE CUSTOMER IDENTIFIED A POSITIVE SHIFT IN CA 19-9 RESULTS AFTER SWITCHING TO A NEW LOT OF REAGENT, AND RE-TESTED PATIENT SAMPLES USING LOT 530 WHICH HAD BEEN INITIALLY TESTED USING LOT 535. LOWER RESULTS OBTAINED USING LOT 530 WERE CONSIDERED CORRECT AND REPORTED TO PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED CA 19-9 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19340557 ↗
• MalfunctionMay 17, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED CA 19-9 RESULTS WITH LOT 535 WHICH ARE DISCORDANT RELATIVE TO REPEAT TESTING WITH LOT 530. THE CUSTOMER IDENTIFIED A POSITIVE SHIFT IN CA 19-9 RESULTS AFTER SWITCHING TO A NEW LOT OF REAGENT, AND RE-TESTED PATIENT SAMPLES USING LOT 530 WHICH HAD BEEN INITIALLY TESTED USING LOT 535. LOWER RESULTS OBTAINED USING LOT 530 WERE CONSIDERED CORRECT AND REPORTED TO PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED CA 19-9 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19340546 ↗
• MalfunctionMay 16, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ADVIA CENTAUR CA 19-9 RESULTS WITH LOT # 535 WHICH WERE DISCORDANT RELATIVE TO LOT# 534 AND PREVIOUS TEST RESULTS. ELEVATED ADVIA CENTAUR CA 19-9 RESULTS WERE OBTAINED FOR 18 PATIENT SAMPLES. THESE RESULTS WERE REPORTED TO THE PHYSICIAN WHO DID NOT QUESTION THE RESULTS. THE CUSTOMER REPEATED THE SAMPLES USING CA 19-9 LOT 534 UPON REVIEW OF PATIENT¿S TEST HISTORY. THE LOWER RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). 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 19334944 ↗
• MalfunctionMay 16, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF DISCORDANT ELEVATED ADVIA CENTAUR CA 19-9 (CA 19-9) RESULTS WITH LOT # 535 WHICH WERE DISCORDANT RELATIVE TO LOT# 534 AND PREVIOUS TEST RESULTS. ELEVATED ADVIA CENTAUR CA 19-9 RESULTS WERE OBTAINED FOR 10 PATIENT SAMPLES. THE RESULTS FOR SAMPLE #16 AND SAMPLE #17 WERE REPORTED TO THE PHYSICIAN, WHO DID NOT QUESTION THE RESULTS. UPON REVIEW OF PATIENT¿S 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 19333555 ↗
• MalfunctionMay 16, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ADVIA CENTAUR CA 19-9(CA 19-9) RESULTS WITH LOT 535 WHICH WERE DISCORDANT RELATIVE TO LOT 534 AND PREVIOUS TEST RESULTS. ELEVATED ADVIA CENTAUR CA 19-9 RESULTS WERE OBTAINED FOR 2 PATIENT SAMPLES. THE RESULT FOR SAMPLE #1 WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE CUSTOMER REPEATED THE SAMPLES USING CA 19-9 LOT 534 UPON REVIEW OF PATIENT¿S TEST HISTORY. THE RESULTS OBTAINED WERE LOWER AND CONSIDERED CORRECT. THE REPEAT RESULT FOR SAMPLE #1 WAS REPORTED TO THE PHYSICIAN(S). 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 19331356 ↗
• MalfunctionMay 13, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ADVIA CENTAUR CA 19-9 RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. CA 19-9 LOT 535 WAS IN USE AT THE TIME. THE CUSTOMER INDICATES THAT CA 19-9 RESULTS FOR 49 PATIENTS WERE FALSELY ELEVATED RELATIVE TO REPEAT TESTING USING IMMULITE 2000 GI-MA. FOR THE PATIENTS IN QUESTION, THE INITIAL ADVIA CENTAUR CA 19-9 RESULTS WERE ABOVE THE EXPECTED VALUE RANGE (>37 U/ML). THESE INITIAL RESULTS WERE NOT REPORTED TO PHYSICIANS. WHEN THE SAME SAMPLES WERE RE-TESTED USING AN ALTERNATE METHOD (GI-MA) IN THE SAME FACILITY, THE RESULTS WERE BELOW THAT ASSAY¿S REFERENCE LIMIT OF 33 U/ML. ALL OF THE OBSERVED DIFFERENCES WERE >30%. THE LOWER RESULTS WERE CONSIDERED CONSISTENT WITH CLINICAL INDICATIONS AND REPORTED AS CORRECT. 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 19296518 ↗
• MalfunctionJan 3, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF DISCORDANT PATIENT RESULTS WITH ADVIA CENTAUR XP CA19-9, LOT 527. ELEVATED INITIAL RESULTS ON 2 PATIENT SAMPLES WERE OBTAINED WITH ADVIA CENTAUR XP CA19-9, LOT 527. THE RESULTS WERE GREATER THAN THE UPPER LIMIT OF NORMAL (ULN) OF 35 U/ML AND WERE NOT REPORTED TO PHYSICIAN(S). THE SAME SAMPLES WERE RETESTED ON AN ALTERNATE METHOD AND THE RESULTS WERE LOWER (LESS THAN THE METHOD CUTOFF OF 37 U/ML), IN AGREEMENT WITH CLINICAL PICTURES OF THE PATIENTS AND REPORTED TO PHYSICIANS AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA19-9 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18437471 ↗
• MalfunctionDec 1, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED CA19-9 RESULT FOR ONE FEMALE PATIENT SAMPLE ON ADVIA CENTAUR XP SYSTEM. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME ADVIA CENTAUR XP SYSTEM, WHICH PRODUCED RESULT SIMILAR TO THE INITIAL DEPRESSED RESULT. THE SAMPLE WAS THEN MEASURED ON TWO DIFFERENT ALTERNATE TESTING METHODS AND THE RESULTS WERE LOWER COMPARED TO THE ADVIA CENTAUR XP RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CA19-9 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18247687 ↗

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-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-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-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-3103-2024 · Jul 26, 2024 · Open, Classified
  ADVIA Centaur 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
• 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-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-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