Atellica IM CA 19-9 10995490Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00630414598178), received between Oct 3, 2019 and Mar 9, 2026 — classified as 48 malfunctions.

The most frequently reported specific device problem is “High Test Results” (38 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-3100-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM CA 19-9 (CA 19-9) RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING WHEN USING CA 19-9 LOT 548. AN INITIAL MILDLY ELEVATED ATELLICA IM CA 19-9 RESULT WAS OBTAINED FOR AN 81-YEAR-OLD WOMAN DIAGNOSED WITH NEOPLASIA. THIS RESULT WAS QUESTIONED AS IT WAS HIGHER THAN EXPECTED FOR THIS PATIENT. THE SAMPLE WAS RE-TESTED USING AN ALTERNATE METHOD (VIDAS), AND A LOWER RESULT (30.93 U/ML) WAS PRODUCED. THIS RESULT WAS CONSIDERED CONSISTENT WITH THE PATIENT¿S CLINICAL HISTORY, AND ACCEPTED AS CORRECT. SUSPECTING POSSIBLE SAMPLE INTERFERENCE, THE CUSTOMER DILUTED THE SAMPLE 10-FOLD FOR ANOTHER ATELLICA IM CA 19-9 TEST, AND A SUBSTANTIALLY HIGHER RESULT WAS OBTAINED. ADDITIONAL DILUTION PRODUCED AN EVEN HIGHER RESULT FOR THIS SAMPLE. THERE ARE NO ALLEGATIONS OF PATIENT HARM OR ANY ADVERSE CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545054 ↗
• MalfunctionNov 17, 2025High Test Results; High Test Results

  THE CUSTOMER NOTIFIED SIEMENS OF AN ELEVATED ATELLICA IM CA 19-9 RESULT ON ONE PATIENT THAT WAS DISCORDANT RELATIVE TO AN ALTERNATE METHOD TEST RESULT OBTAINED ON THE SAME SAMPLE AT A DIFFERENT LAB. THE RESULTS WERE REPORTED. THE ATTENDING PHYSICIAN CONTINUED PATIENT TREATMENT BASED ON THE RESULTS FROM ANOTHER INSTITUTION, WHERE THE PATIENT WAS BEING FOLLOWED FOR A DIAGNOSIS OF BREAST MALIGNANT NEOPLASM. THE CUSTOMER SHARED HISTORICAL RESULTS BEGINNING (B)(6) 2024, WHEN THE CUSTOMER HAD BEEN USING AN ALTERNATE METHOD AND SWITCHED TO ATELLICA IM CA 19-9. NO OTHER INFORMATION WAS PROVIDED ABOUT THE RESULTS, METHODS OR TREATMENT AT THE OTHER INSTITUTION OR WHY THE SIEMENS CUSTOMER WAS TESTING FOR CA 19-9 WHILE THE PATIENT WAS BEING TREATED AT ANOTHER INSTITUTION. 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 23568739 ↗
• MalfunctionMar 14, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A DEPRESSED ATELLICA IM CA 19 9 (CA 19 9) RESULT WHICH WAS DISCORDANT RELATIVE TO THE DILUTED RESULT WHEN USING LOT 541. AN INITIAL DEPRESSED RESULT WAS OBTAINED FOR THE PATIENT SAMPLE IN QUESTION. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS DILUTED (1:2 AND 1:10) AND RETESTED ON THE ORIGINAL ANALYZER WHICH OBTAINED AN ELEVATED RESULT. THE ELEVATED RESULT WAS CONSIDERED CORRECT AND ISSUED ON THE CORRECTED REPORT TO THE PHYSICIAN. THE SAME SAMPLE WAS ALSO PROCESSED ON AN ALTERNATE METHOD WHICH RECOVERED ELEVATED RESULT. THERE ARE NO ALLEGATIONS OF ANY PATIENT HARM RESULTING FROM THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21604095 ↗
• MalfunctionMar 6, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A DEPRESSED ATELLICA IM CA 19 9 (CA 19 9) RESULT WHICH WAS DISCORDANT RELATIVE TO THE DILUTED RESULT WHEN USING LOT 541. AN INITIAL DEPRESSED RESULT WAS OBTAINED FOR THE PATIENT SAMPLE IN QUESTION. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLE WAS RETESTED ON THE ORIGINAL ANALYZER WHICH PRODUCED A SIMILAR DEPRESSED RESULT. LATER, THE SAME SAMPLE WAS DILUTED (1:10) AND RETESTED ON THE ORIGINAL INSTRUMENT WHICH OBTAINED AN ELEVATED RESULT. THE ELEVATED RESULT WAS CONSIDERED CORRECT AND ISSUED ON THE CORRECTED REPORT TO THE PHYSICIAN. FOR TROUBLESHOOTING PURPOSES, THE SAME SAMPLE WAS TESTED USING SERIAL DILUTION ON THE ORIGINAL ANALYZER AND ELEVATED RESULTS WERE OBTAINED COMPARED TO THE NEAT RESULT. THE SAMPLE WAS ALSO TESTED BOTH NEAT AND DILUTED ON AN ALTERNATE METHOD TESTING AND OBTAINED ELEVATED RESULTS. THERE ARE NO ALLEGATIONS OF ANY PATIENT HARM RESULTING FROM THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21534110 ↗
• MalfunctionJan 15, 2025Low Test Results; Low Test Results

  CUSTOMER REPORTED AN OBSERVATION OF A DISCORDANT PATIENT RESULT WITH THE ATELLICA IM CA 19-9 ASSAY, LOT 539. THE PATIENT IS A FEMALE CANCER PATIENT UNDERGOING CHEMOTHERAPY. THE INITIAL RESULT (647.79 U/ML) WAS QUESTIONED BY THE PATIENT AND NOT BY THE PHYSICIAN. ALSO, THE PATIENT WENT TO A DIFFERENT LABORATORY FOR CA 19-9 TESTING. AS A RESULT, THE SAME PATIENT SAMPLE WAS REPEATED AND OBTAINED >700 U/ML AND 1635.27 U/ML WITH AUTO DILUTION. THIS RESULT WAS CONSIDERED CORRECT BY THE PATIENT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21157638 ↗
• MalfunctionDec 12, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER IDENTIFIED DISCORDANT ATELLICA IM ATELLICA IM CA19-9 (CA 19-9) PATIENT RESULTS AFTER A QUALITY CONTROL (QC) ISSUE OCCURRED. AFTER THE QC ISSUE WAS IDENTIFIED, PATIENT SAMPLES PREVIOUSLY TESTED WERE RETESTED ON A DIFFERENT ATELLICA IM INSTRUMENT AND THE DISCORDANCE WAS IDENTIFIED. THE COMPLAINT INDICATES THAT THE INITIAL RESULTS WERE REPORTED BUT NOT QUESTIONED BY PHYSICIANS AND THE RETEST RESULTS WERE REPORTED AS CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CA 19-9 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20915110 ↗
• MalfunctionNov 21, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED A DEPRESSED ATELLICA IM CA 19-9 RESULT ON A PATIENT SAMPLE THAT WAS HIGHER WHEN THE SAMPLE WAS TESTED WITH AN ALTERNATE METHOD. IT IS UNKNOWN IF THE DEPRESSED ATELLICA IM CA 19-9 RESULT WAS REPORTED TO THE PHYSICIAN. THERE IS NO INDICATION OF A CANCER DIAGNOSIS, HOWEVER THE ATELLICA IM CA 19-9 RESULT WAS EXPECTED TO BE HIGHER BECAUSE THE PATIENT HAD AN ELEVATED CA50 RESULT. 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 20743568 ↗
• MalfunctionSep 18, 2024High Test Results; High Test Results

  THE CUSTOMER OBTAINED ELEVATED ATELLICA IM CA19-9 RESULTS ON TWO PATIENT SAMPLES TESTED WITH LOT 537 ON ANALYZER IRH007741945. THE INITIAL RESULTS WERE REPORTED AND QUESTIONED BY THE PHYSICIAN. RETEST RESULTS ON THE SAME ANALYZER WERE SIMILARLY ELEVATED. THE EXPECTED CORRECT RESULTS WERE CLOSE TO ZERO / NEGATIVE. A CORRECTED REPORT WAS ISSUED, BUT THE FINAL RESULTS WERE NOT PROVIDED IN THIS TICKET. THERE IS NO ALLEGATION 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 20244494 ↗
• MalfunctionAug 27, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF DEPRESSED ATELLICA IM CA 19 9 RESULT WITH LOT 539 WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING USING DILUTION. AN INITIAL DEPRESSED CA 19-9 RESULT WAS OBTAINED FOR ONE (1) PATIENT SAMPLE. THE INITIAL DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLE WAS DILUTED (1:10), RETESTED ON THE SAME INSTRUMENT AND OBTAINED A HIGHER RESULT. THE HIGHER RESULT WAS CONSIDERED CORRECT SINCE IT MATCHED THE CLINICAL CONDITION OF THE PATIENT AND ISSUED ON THE CORRECTED REPORT TO THE PHYSICIAN. FOR TROUBLESHOOTING PURPOSES, THE SAME SAMPLE WAS ALSO TESTED ON AN ALTERNATE ANALYZER AND OBTAINED A DEPRESSED RESULT. THE SAMPLE WAS THEN DILUTED (1:10); RETESTED AND OBTAINED A HIGHER RESULT. 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 20074710 ↗
• MalfunctionMay 22, 2024High Test Results; High Test Results

  THE CUSTOMER OBTAINED ELEVATED ATELLICA IM CA19-9 RESULTS FOR ONE PATIENT THAT WERE DISCORDANT RELATIVE TO RETEST AND TO THE PATIENT'S HISTORICAL RESULTS. THE PATIENT, WHO WAS BEING TESTED FOR CA19-9 OVER THE PAST FEW YEARS BECAUSE OF A FAMILY HISTORY OF CANCER, REQUESTED A CA 19-9 TEST WHEN SHE WENT TO THE CUSTOMER SITE MEDICAL CENTER FOR EVALUATION OF A MOLE IN HER LEFT LEG. THE ATELLICA IM CA19-9 RESULT OBTAINED WAS ELEVATED. ADDITIONAL SAMPLES WERE DRAWN AND TESTED ON 2 OTHER DAYS AND ONE RESULT WAS ELEVATED AND THE OTHER RESULT WAS WITHIN THE NORMAL REFERENCE RANGE. THERE IS NO ALLEGATION OF ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19378836 ↗
• MalfunctionMay 22, 2024High Test Results; High Test Results

  THE CUSTOMER OBTAINED ELEVATED ATELLICA IM CA19-9 RESULTS FOR ONE PATIENT THAT WERE DISCORDANT RELATIVE TO RETEST AND TO THE PATIENT'S HISTORICAL RESULTS. THE PATIENT, WHO WAS BEING TESTED FOR CA19-9 OVER THE PAST FEW YEARS BECAUSE OF A FAMILY HISTORY OF CANCER, REQUESTED A CA 19-9 TEST WHEN SHE WENT TO THE CUSTOMER SITE MEDICAL CENTER FOR EVALUATION OF A MOLE IN HER LEFT LEG. THE ATELLICA IM CA19-9 RESULT OBTAINED WAS ELEVATED. ADDITIONAL SAMPLES WERE DRAWN AND TESTED ON 2 OTHER DAYS AND ONE RESULT WAS ELEVATED AND THE OTHER RESULT WAS WITHIN THE NORMAL REFERENCE RANGE. THERE IS NO ALLEGATION OF ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370594 ↗
• MalfunctionNov 29, 2023High Test Results; High Test Results

  THE CUSTOMER TESTED 3 SAMPLES FROM THE SAME PATIENT ON DIFFERENT DAYS FOR CA19-9 ON ATELLICA IM ANALYZER IRH033422247. THE RESULTS WERE ELEVATED AND DID NOT MATCH WITH THE PATIENT'S CLINICAL HISTORY OR DIAGNOSIS. THE PATIENT WAS TESTED LATER AT A DIFFERENT LAB ON AN UNKNOWN CA19-9 METHOD AND THE RESULT WAS LOWER. IT IS UNKNOWN WHETHER THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN.THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA19-9 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18230288 ↗
• MalfunctionNov 29, 2023High Test Results; High Test Results

  THE CUSTOMER TESTED 3 SAMPLES FROM THE SAME PATIENT ON DIFFERENT DAYS FOR CA19-9 ON ATELLICA IM ANALYZER (B)(6). THE RESULTS WERE ELEVATED AND DID NOT MATCH WITH THE PATIENT'S CLINICAL HISTORY OR DIAGNOSIS. THE PATIENT WAS TESTED LATER AT A DIFFERENT LAB ON AN UNKNOWN CA19-9 METHOD AND THE RESULT WAS LOWER. IT IS UNKNOWN WHETHER THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA19-9 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18230278 ↗
• MalfunctionNov 29, 2023High Test Results; High Test Results

  THE CUSTOMER TESTED 3 SAMPLES FROM THE SAME PATIENT ON DIFFERENT DAYS FOR CA19-9 ON ATELLICA IM ANALYZER (B)(4). THE RESULTS WERE ELEVATED AND DID NOT MATCH WITH THE PATIENT'S CLINICAL HISTORY OR DIAGNOSIS. THE PATIENT WAS TESTED LATER AT A DIFFERENT LAB ON AN UNKNOWN CA19-9 METHOD AND THE RESULT WAS LOWER. IT IS UNKNOWN WHETHER THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA19-9 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18230268 ↗
• MalfunctionOct 27, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED PATIENT RESULTS WHEN USING ATELLICA IM CA19-9. THE PATIENTS RESULTED HIGHER THAN 37 U/ML, WHICH WAS UNEXPECTED BY THE CUSTOMER AS PATIENTS HAD NO DISEASE STATE. THE CUSTOMER DID NOT REPORT THE >37 U/ML ATELLICA IM CA19-9 RESULTS BUT TESTED ON AN ALTERNATE TEST METHOD FOR COMPARISON AND RESULTS WERE LOWER AND CONSIDERED CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED CA19-9 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18026415 ↗
• MalfunctionOct 27, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED PATIENT RESULT WHEN USING ATELLICA IM CA19-9. THE PATIENT RESULTED HIGHER THAN 37 U/ML, WHICH WAS UNEXPECTED BY THE CUSTOMER AS PATIENT HAD NO DISEASE STATE. THE CUSTOMER DID NOT REPORT THE >37 U/ML ATELLICA IM CA19-9 RESULT BUT TESTED ON AN ALTERNATE TEST METHOD FOR COMPARISON AND RESULT WAS LOWER AND CONSIDERED CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED CA19-9 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18026414 ↗
• MalfunctionOct 27, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED PATIENT RESULT WHEN USING ATELLICA IM CA19-9. THE PATIENT RESULTED HIGHER THAN 37 U/ML, WHICH WAS UNEXPECTED BY THE CUSTOMER AS PATIENT HAD NO DISEASE STATE. THE CUSTOMER DID NOT REPORT THE >37 U/ML ATELLICA IM CA19-9 RESULT BUT TESTED ON AN ALTERNATE TEST METHOD FOR COMPARISON AND RESULT WAS LOWER AND CONSIDERED CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED CA19-9 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18026412 ↗
• MalfunctionOct 27, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED PATIENT RESULTS WHEN USING ATELLICA IM CA19-9. THE PATIENTS RESULTED HIGHER THAN 37 U/ML, WHICH WAS UNEXPECTED BY THE CUSTOMER AS PATIENTS HAD NO DISEASE STATE. THE CUSTOMER DID NOT REPORT THE >37 U/ML ATELLICA IM CA19-9 RESULTS BUT TESTED ON AN ALTERNATE TEST METHOD FOR COMPARISON AND RESULTS WERE LOWER AND CONSIDERED CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED CA19-9 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18026410 ↗
• MalfunctionOct 27, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED PATIENT RESULTS WHEN USING ATELLICA IM CA19-9. THE PATIENTS RESULTED HIGHER THAN 37 U/ML, WHICH WAS UNEXPECTED BY THE CUSTOMER AS PATIENTS HAD NO DISEASE STATE. THE CUSTOMER DID NOT REPORT THE >37 U/ML ATELLICA IM CA19-9 RESULTS BUT TESTED ON AN ALTERNATE TEST METHOD FOR COMPARISON AND RESULTS WERE LOWER AND CONSIDERED CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED CA19-9 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18026398 ↗
• MalfunctionSep 23, 2023High Test Results; High Test Results

  THE CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTS OBSERVATION OF A DISCORDANT RESULT FOR A SAMPLE FROM A PATIENT WHEN RUNNING CA 19-9 LOT 522 ON ATELLICA IM 1600 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON ANOTHER ATELLICA IM 1600 ANALYZER AND COMPARABLE RESULT WAS OBTAINED. THE NUMERICAL RESULT FOR THE ALTERNATE METHOD AND THE REFERENCE RANGE WERE NOT PROVIDED. HOWEVER, THE CUSTOMER STATED THAT THE ALTERNATE METHOD RESULT WAS NORMAL. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, CA 19.9 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17804974 ↗
• MalfunctionSep 22, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A DISCORDANT DEPRESSED RESULT FOR ONE PATIENT SAMPLE WHEN RUNNING CA 19-9 LOT 522 ON ATELLICA IM 1600 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE SAMPLE WAS REPEATED MULTIPLE TIMES WITH DILUTION ON ANOTHER ATELLICA IM 1600 ANALYZER AND HIGHER RESULTS WERE OBTAINED. 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 17798369 ↗
• MalfunctionSep 22, 2023High Test Results; High Test Results

  THE CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTS OBSERVATION OF A DISCORDANT RESULT FOR A SAMPLE FROM A PATIENT WHEN RUNNING CA 19-9 LOT 522 ON ATELLICA IM 1600 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON ANOTHER ATELLICA IM 1600 ANALYZER AND COMPARABLE RESULT WAS OBTAINED. THE NUMERICAL RESULT FOR THE ALTERNATE METHOD AND THE REFERENCE RANGE WERE NOT PROVIDED. HOWEVER, THE CUSTOMER STATED THAT THE ALTERNATE METHOD RESULT WAS NORMAL. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, CA 19.9 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17796893 ↗
• MalfunctionSep 22, 2023High Test Results; High Test Results

  THE CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTS OBSERVATION OF DISCORDANT RESULTS FOR TWO PATIENT SAMPLES WHEN RUNNING CA 19-9 LOT 522 ON ATELLICA IM 1600 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON ANOTHER ATELLICA IM 1600 ANALYZERS AND COMPARABLE RESULTS WERE OBTAINED. THE NUMERICAL RESULTS FOR THE ALTERNATE METHOD AND THE REFERENCE RANGE WERE NOT PROVIDED. HOWEVER, THE CUSTOMER STATED THAT THE ALTERNATE METHOD RESULTS WERE NORMAL. 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 17796881 ↗
• MalfunctionSep 22, 2023High Test Results; High Test Results

  THE CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTS OBSERVATION OF DISCORDANT RESULTS FOR THREE PATIENT SAMPLES WHEN RUNNING CA 19-9 LOT 522 ON ATELLICA IM 1600 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON ANOTHER ATELLICA IM 1600 ANALYZERS AND COMPARABLE RESULTS WERE OBTAINED. THE NUMERICAL RESULTS FOR THE ALTERNATE METHOD AND THE REFERENCE RANGE WERE NOT PROVIDED. HOWEVER, THE CUSTOMER STATED THAT THE ALTERNATE METHOD RESULTS WERE NORMAL. 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 17796878 ↗
• MalfunctionSep 22, 2023High Test Results; High Test Results

  THE CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTS OBSERVATION OF A DISCORDANT RESULT FOR A SAMPLE FROM A PATIENT WHEN RUNNING CA 19-9 LOT 522 ON ATELLICA IM 1600 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON ANOTHER ATELLICA IM 1600 ANALYZER AND COMPARABLE RESULT WAS OBTAINED. THE NUMERICAL RESULT FOR THE ALTERNATE METHOD AND THE REFERENCE RANGE WERE NOT PROVIDED. HOWEVER, THE CUSTOMER STATED THAT THE ALTERNATE METHOD RESULT WAS NORMAL. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, CA 19.9 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17796871 ↗

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-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-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-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-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