Atellica IM CA 19-9Recalls & reported problems across all models

We found 3 models of Atellica IM CA 19-9 by Siemens Healthcare Diagnostics Inc. in the FDA's device registry (GUDID). Together they are named in 121 adverse event reports in the FDA's MAUDE database, received between Oct 3, 2019 and Mar 9, 2026 — classified as 121 malfunctions.

The most frequently reported specific device problem is “High Test Results” (95 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 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

Atellica IM 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-3102-2024 · 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-3101-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. 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-3100-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Atellica IM CA 19-9 problems

Atellica IM CA 19-9 models

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

• Atellica IM CA 19-9 10995489

  SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
  1 recall73 reports
• Atellica IM CA 19-9 10995490

  SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
  1 recall48 reports
• Atellica IM CA 19-9 11206239

  SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
  1 recall0 reports

Recent Atellica IM 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.

• 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 ↗
• MalfunctionMar 4, 2026High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM CA 19-9 RESULT WITH LOT# 549, WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING ON AN ALTERNATE METHOD. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER, WHICH PRODUCED SIMILARLY ELEVATED RESULT. THE SAMPLE WAS THEN REPEATED ON AN ALTERNATE ATELLICA INSTRUMENT AND OBTAINED SIMILAR ELEVATED RESULT AND CONSIDERED CORRECT. THE SAMPLE WAS TESTED ON THE ALTERNATE METHOD WHICH PRODUCED A LOWER RESULT. THE REPEAT RESULT OBTAINED ON THE ALTERNATE METHOD WAS CONSIDERED CORRECT AND REPORTED 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 24504542 ↗
• MalfunctionJan 1, 2026High Test Results

  THE CUSTOMER REPORTED OBSERVATION OF ELEVATED ATELLICA IM CA 19-9 RESULTS WHEN USING LOT# 548, WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING ON AN ALTERNATE METHOD. AN INITIAL ELEVATED ATELLICA IM CA 19-9 RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. THE SAME SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER AND OBTAINED A SIMILARLY ELEVATED RESULT. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS DILUTED MANUALLY (X20 TIMES) AND REPEATED ON THE ORIGINAL ANALYZER FOR TROUBLESHOOTING PURPOSES, WHICH PRODUCED A SIMILARLY ELEVATED RESULT. THE SAMPLE WAS THEN TREATED WITH POLYETHYLENE GLYCOL 6000 (PEG), AND WAS REPEATED ON THE ORIGINAL ANALYZER FOR TROUBLESHOOTING PURPOSES AND OBTAINED A LOWER RESULT. THEN THE SAMPLE WAS ALSO RETESTED USING AN ALTERNATE METHOD, WHICH OBTAINED A MUCH LOWER RESULT. THE LOWER RESULT OBTAINED USING THE ALTERNATE METHOD WAS CONSIDERED CORRECT BASED ON THE CLINICAL PICTURE OF THE AFFECTED 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 23939472 ↗
• 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 ↗
• MalfunctionOct 22, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF DEPRESSED ATELLICA IM CA 19-9 (CA 19-9) RESULTS FOR NEAT (UNDILUTED) SAMPLES WHICH WERE DISCORDANT RELATIVE TO TESTING OF THE SAME SAMPLES FOLLOWING DILUTION WHEN USING CA 19-9 LOT: 547. THE CUSTOMER REPORTS OBSERVATION OF INITIAL NEAT (UNDILUTED) SAMPLE RESULTS WHICH ARE DEPRESSED RELATIVE TO TESTING OF DILUTED SAMPLES, WHERE THE HIGHER RESULTS FROM THE DILUTED SAMPLES ARE CONSISTENT WITH THE PATIENT¿S CLINICAL CONDITION. THE INITIAL (UNDILUTED) CA 19-9 RESULT FOR THIS PATIENT WAS HIGH, BUT NOT ABOVE THE ASSAY¿S MEASURING RANGE (1.20-700.00 U/ML). THE INITIAL RESULT WAS NOT REPORTED TO PHYSICIANS. WHEN DILUTED, THE SAMPLE PRODUCED MUCH HIGHER RESULTS. ADDITIONAL DILUTION TESTING PERFORMED FOR INVESTIGATION SEVERAL DAYS LATER REPRODUCED THE PATTERN SEEN IN INITIAL TESTING. THE INITIAL (UNDILUTED) RESULTS FOR THIS SAMPLE WERE IDENTIFIED AS FALSELY DEPRESSED RELATIVE TO THE HIGHER RESULTS OBTAINED FOLLOWING SAMPLE DILUTION, WHICH WERE CONSIDERED CONSISTENT WITH THE PATIENT¿S CLINICAL PICTURE. 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 23361488 ↗
• MalfunctionOct 22, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF DEPRESSED ATELLICA IM CA 19-9 (CA 19-9) RESULTS FOR NEAT (UNDILUTED) SAMPLES WHICH WERE DISCORDANT RELATIVE TO TESTING OF THE SAME SAMPLES FOLLOWING DILUTION WHEN USING CA 19-9 LOT 547. THE CUSTOMER REPORTS OBSERVATION OF INITIAL NEAT (UNDILUTED) SAMPLE RESULTS WHICH ARE DEPRESSED RELATIVE TO TESTING OF DILUTED SAMPLES, WHERE THE HIGHER RESULTS FROM THE DILUTED SAMPLES ARE CONSISTENT WITH THE PATIENT¿S CLINICAL CONDITION. THE INITIAL (UNDILUTED) CA 19-9 RESULT FOR THIS PATIENT WAS HIGH, BUT NOT ABOVE THE ASSAY¿S MEASURING RANGE (1.20-700.00 U/ML). THE INITIAL RESULT WAS NOT REPORTED TO PHYSICIANS. WHEN DILUTED, THE SAMPLE PRODUCED MUCH HIGHER RESULTS. ADDITIONAL DILUTION TESTING PERFORMED FOR INVESTIGATION SEVERAL DAYS LATER REPRODUCED THE PATTERN SEEN IN INITIAL TESTING. THE INITIAL (UNDILUTED) RESULTS FOR THIS SAMPLE WERE IDENTIFIED AS FALSELY DEPRESSED RELATIVE TO THE HIGHER RESULTS OBTAINED FOLLOWING SAMPLE DILUTION, WHICH WERE CONSIDERED CONSISTENT WITH THE PATIENT¿S CLINICAL PICTURE. 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 23361486 ↗
• MalfunctionJul 4, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED OBSERVATION OF ELEVATED ATELLICA IM CA 19-9 RESULTS WHEN USING LOT# 546 WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING ON AN ALTERNATE METHOD. AN INITIAL ELEVATED ATELLICA IM CA 19-9 RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. THE SAME SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER AND OBTAINED A SIMILARLY ELEVATED RESULT. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS TESTED AFTER PEG6000 (POLYETHYLENE GLYCOL 6000) TREATMENT ON THE SAME ANALYZER FOR TROUBLESHOOTING PURPOSES AND OBTAINED A LOWER RESULT. THEN THE SAMPLE WAS ALSO RETESTED USING AN ALTERNATE TEST METHOD (BECKMAN COULTER UNICEL DXI 800) WHICH OBTAINED A MUCH LOWER RESULT. THE LOWER RESULT OBTAINED USING THE ALTERNATE METHOD WAS CONSIDERED CORRECT BASED ON THE CLINICAL PICTURE OF THE AFFECTED 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 22402523 ↗
• MalfunctionJun 6, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  THE CUSTOMER REPORTS OBSERVATION OF DISCORDANCE BETWEEN NEAT AND DILUTED RESULTS WITH ATELLICA IM CA 19 9 (CA 19 9), LOT 546. THE AFFECTED PATIENT¿S SAMPLES WERE DRAWN INTO TWO COLLECTION TUBES. FOR THE FIRST SAMPLE, AN INITIAL RESULT WITH AN ABOVE ASSAY RANGE FLAG WAS OBTAINED. THE SAMPLE WAS THEN DILUTED (1:10) AND RETESTED ON THE ORIGINAL ANALYZER, WHICH OBTAINED A HIGHER RESULT. ON THE FOLLOWING DAY, THE SAME SAMPLE WAS RETESTED NEAT WHICH OBTAINED A LOWER RESULT. FOR THE SECOND SAMPLE, THE INITIAL NEAT TEST OBTAINED A LOWER RESULT. ON THE FOLLOWING DAY, THE SAME SAMPLE WAS RETESTED ON THE ORIGINAL ANALYZER, WHICH OBTAINED A RESULT WITH ABOVE ASSAY RANGE FLAG. THE SAMPLE WAS THEN DILUTED (1:10) AND OBTAINED A HIGHER RESULT. THE EXPECTED RESULT FOR THE AFFECTED PATIENT REMAINS UNKNOWN. HOWEVER, THE CUSTOMER ALLEGED DISCORDANCE BETWEEN THE NEAT AND DILUTED RESULTS. 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 22157780 ↗
• MalfunctionJun 6, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  THE CUSTOMER REPORTS OBSERVATION OF DISCORDANCE BETWEEN NEAT AND DILUTED RESULTS WITH ATELLICA IM CA 19 9 (CA 19 9), LOT 546. THE AFFECTED PATIENT¿S SAMPLES WERE DRAWN INTO TWO COLLECTION TUBES. FOR THE FIRST SAMPLE, AN INITIAL RESULT WITH AN ABOVE ASSAY RANGE FLAG WAS OBTAINED. THE SAMPLE WAS THEN DILUTED (1:10) AND RETESTED ON THE ORIGINAL ANALYZER, WHICH OBTAINED A HIGHER RESULT. ON THE FOLLOWING DAY, THE SAME SAMPLE WAS RETESTED NEAT WHICH OBTAINED A LOWER RESULT. FOR THE SECOND SAMPLE, THE INITIAL NEAT TEST OBTAINED A LOWER RESULT. ON THE FOLLOWING DAY, THE SAME SAMPLE WAS RETESTED ON THE ORIGINAL ANALYZER, WHICH OBTAINED A RESULT WITH ABOVE ASSAY RANGE FLAG. THE SAMPLE WAS THEN DILUTED (1:10) AND OBTAINED A HIGHER RESULT. THE EXPECTED RESULT FOR THE AFFECTED PATIENT REMAINS UNKNOWN. HOWEVER, THE CUSTOMER ALLEGED DISCORDANCE BETWEEN THE NEAT AND DILUTED RESULTS. 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 22157735 ↗
• 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 ↗
• MalfunctionNov 8, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM CA 19-9 RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE METHOD TESTING WHEN USING REAGENT LOT 541. AN INITIAL ELEVATED CA 19-9 RESULT (ABOVE REFERENCE RANGE) WAS OBTAINED FOR ONE (1) PATIENT SAMPLE. THE INITIAL RESULT WHICH WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. FOR COMPARISON, THE SAME SAMPLE WAS TESTED ON AN ALTERNATE ATELLICA IM ANALYZER, OBTAINED A SIMILAR HIGHER RESULT, AND REPORTED TO THE PHYSICIAN(S). A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT THE NEXT DAY, TESTED ON AN ALTERNATE TESTING METHOD AND OBTAINED A LOWER RESULT. HOWEVER, THE CUSTOMER DID NOT CONFIRM WHICH RESULT WAS CONSIDERED CORRECT. 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 20638887 ↗

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