Atellica IM CA 19-9 10995489Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00630414598161), received between Jun 12, 2020 and Mar 4, 2026 — classified as 73 malfunctions.

The most frequently reported specific device problem is “High Test Results” (57 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-3101-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionOct 23, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED AN OBSERVATION OF DISCORDANCE BETWEEN THE UNDILUTED AND DILUTED RESULTS OF A PATIENT SERUM SAMPLE TESTED WITH ATELLICA IM CA 19-9 LOT 539. THE INITIAL UNDILUTED RESULT WAS LOWER THAN EXPECTED BASED ON THE CLINICAL HISTORY OF THE PATIENT. THE RESULT WAS NOT REPORTED AND WAS RETESTED BY DILUTION (ON-BOARD AND MANUAL) ON A DIFFERENT ATELLICA IM ANALYZER. THE RESULTS WERE HIGHER AS EXPECTED AND CONSIDERED CORRECT. THERE ARE NO REPORTS OF ALTERED TREATMENT OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LOW CA 19-9 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20513638 ↗
• MalfunctionOct 8, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM CA 19-9 RESULTS ON TWO SAMPLES FROM THE SAME PATIENT (61-YEAR-OLD FEMALE) WITH LOT#: 539 WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING ON AN ALTERNATE TESTING METHOD. THE PATIENT WAS TESTED, THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A NEW SAMPLE WAS DRAWN AND TESTED WHICH PRODUCED AN ELEVATED RESULT. THE SAMPLE WAS SENT TO OTHER LAB FOR ALTERNATE-METHOD TESTING (ROCHE) WHICH RETURNED NORMAL-RANGE RESULT. THE REGION SHARED TEST DATA THAT WERE PERFORMED FOR INVESTIGATION/TROUBLESHOOTING PURPOSES. THERE ARE NO ALLEGATIONS OF ANY PATIENT HARM RESULTING FROM THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20394712 ↗
• MalfunctionOct 8, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM CA 19-9 RESULTS ON TWO SAMPLES FROM THE SAME PATIENT (61-YEAR-OLD FEMALE) WITH LOT# 539 WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING ON AN ALTERNATE TESTING METHOD. THE PATIENT WAS TESTED, THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A NEW SAMPLE WAS DRAWN AND TESTED WHICH PRODUCED AN ELEVATED RESULT. THE SAMPLE WAS SENT TO OTHER LAB FOR ALTERNATE-METHOD TESTING WHICH RETURNED NORMAL-RANGE RESULT. THE REGION SHARED TEST DATA THAT WERE PERFORMED FOR INVESTIGATION/TROUBLESHOOTING PURPOSES. THERE ARE NO ALLEGATIONS OF ANY PATIENT HARM RESULTING FROM THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20394701 ↗
• MalfunctionAug 27, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED ELEVATED ATELLICA IM CA19-9 LOT 535 RESULTS ON SAMPLES FROM A 69-YEAR-OLD FEMALE UNDERGOING CHEMOTHERAPY. THE DOCTOR IS CONTESTING THE ATELLICA IM CA19-9 LOT 535 RESULTS. SAMPLES FROM THE PATIENT WERE TESTED AND RESULTED AT THE HIGH LIMIT OF THE ANALYTICAL MEASURING RANGE (AMI) OF THE ASSAY (1.20¿700 U/ML PER ASSAY INSTRUCTIONS FOR USE). DILUTION TESTING WAS PERFORMED, AND THE RESULTS DID NOT DEMONSTRATE THE EXPECTED DILUTION RECOVERY. THE SAMPLES WERE SENT TO A NON-CUSTOMER LABORATORY FOR DILUTION TESTING WITH AN ALTERNATE METHOD. THE DILUTION RESULTS BETWEEN ATELLICA IM CA 19-9 AND THE ALTERNATE METHOD WERE SIMILAR. 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 20074722 ↗
• MalfunctionAug 27, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED ELEVATED ATELLICA IM CA19-9 LOT 535 RESULTS ON SAMPLES FROM A 69-YEAR-OLD FEMALE UNDERGOING CHEMOTHERAPY. THE DOCTOR IS CONTESTING THE ATELLICA IM CA19-9 LOT 535 RESULTS. SAMPLES FROM THE PATIENT WERE TESTED AND RESULTED AT THE HIGH LIMIT OF THE ANALYTICAL MEASURING RANGE (AMI) OF THE ASSAY (1.20¿700 U/ML PER ASSAY INSTRUCTIONS FOR USE). DILUTION TESTING WAS PERFORMED, AND THE RESULTS DID NOT DEMONSTRATE THE EXPECTED DILUTION RECOVERY. THE SAMPLES WERE SENT TO A NON-CUSTOMER LABORATORY FOR DILUTION TESTING WITH AN ALTERNATE METHOD. THE DILUTION RESULTS BETWEEN ATELLICA IM CA 19-9 AND THE ALTERNATE METHOD WERE SIMILAR. 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 20074720 ↗
• MalfunctionAug 15, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM CA 19-9 (CA 19-9) RESULT FROM LOT 535 WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WITH LOT 537. THE CUSTOMER RECEIVED SIEMENS FIELD ACTION NOTIFICATION AIMC 24-14.A.OUS, INFORMING OF RESULT BIAS ASSOCIATED WITH ATELLICA IM CA 19-9 LOTS ENDING IN 535. AS A RESULT, THEY RE-TESTED STORED SAMPLES FOR WHICH CA 19-9 RESULTS HAD BEEN PREVIOUSLY REPORTED FROM LOT 535. FOR ONE SAMPLE, THEY IDENTIFIED DISCORDANCE BETWEEN INITIAL AND REPEAT RESULTS, WHERE THE INITIAL RESULT WAS >3X HIGHER THAN THE REPEAT. THE RESULT REPORT WAS CORRECTED FOR THIS PATIENT. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE DISCORDANT RESULT. THE CUSTOMER HAS CEASED USING CA 19-9 LOT 535, IN ACCORDANCE WITH THE FIELD-ACTION NOTIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19996694 ↗
• MalfunctionMay 24, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ADVIA CENTAUR CA 19-9 LOT 535 PATIENT SAMPLE RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING (ATELLICA IM CA 19-9 LOT 533). FOR THE PATIENT SAMPLES 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 PHYSICIAN(S). WHEN THE SAME SAMPLES WERE RE-TESTED USING AN ALTERNATE METHOD ( ATELLICA IM CA 19-9 LOT 533), THE RESULTS WERE LOWER, WHICH WERE REPORTED TO PHYSICIAN(S) AS CORRECT. RE 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 19389223 ↗
• MalfunctionMar 26, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A DISCORDANCE BETWEEN RESULTS OF ONE PATIENT SAMPLE WHEN TESTING WITH ATELLICA IM CA 19-9 LOT 531. THE INITIAL SAMPLE RESULT WAS GREATER THAN THE ASSAY MEASURING INTERVAL AND WAS THEREFORE TESTED DILUTED PER THE ASSAY INSTRUCTION FOR USE (IFU). THE CUSTOMER NOTED THAT THE SAMPLE WAS PROCESSED WHILE QUALITY CONTROL (QC) WAS RUNNING, AND THE RESULTS WERE OUT OF RANGE. THE CUSTOMER RECALIBRATED, QC WAS RETESTED AND FOUND TO BE ACCEPTABLE, AND THE SAMPLE WAS RETESTED DILUTED SEVERAL TIMES. OUT OF THE RESULTS OBTAINED, ONE WAS DISCORDANT RELATIVE TO THE OTHER RESULTS. IT WAS NOT CONFIRMED IF THE DISCORDANT RESULT WAS REPORTED TO PHYSICIAN, BUT THE CUSTOMER INDICATED THAT A CORRECTED REPORT WAS ISSUED. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA19-9 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977055 ↗
• MalfunctionFeb 2, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A DISCORDANT (HIGH) CA 19-9 RESULT OF A MALE PATIENT SAMPLE ON ATELLICA IM 1600 INSTRUMENT, LOT 528 VS. AN ALTERNATE METHOD. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THIS SAME SAMPLE WAS RETESTED ON AN ALTERNATE TESTING PLATFORM, AND THE RESULT WAS LOWER. THE ALTERNATE TESTING PLATFORM RESULT WAS CONSIDERED AS THE CORRECT RESULT BY THE PHYSICIAN(S).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18629247 ↗
• MalfunctionJan 3, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF DISCORDANT RESULTS FOR A PATIENT WHEN TESTED WITH ATELLICA IM CA19-9, LOT 528. AN ELEVATED (GREATER THAN THE UPPER LIMIT OF NORMAL (ULN) OF 35 U/ML) ATELLICA IM CA19-9, LOT 528 RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. THE SAME SAMPLE WAS RETESTED, AND THE RESULT WAS ALSO ELEVATED. THE SAME SAMPLE WAS RETESTED ON AN ALTERNATE TEST METHOD AND THE RESULT WAS LOWER. THE ALTERNATE METHOD RESULT WAS ACCEPTED BY THE PHYSICIAN 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 18440140 ↗
• MalfunctionDec 15, 2023High Test Results; High Test Results

  THE CUSTOMER OBTAINED REPEAT ELEVATED RESULTS ON ONE PATIENT SAMPLE USING ATELLICA IM CA 19-9 LOT 528. THE ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND RESULT WAS LOWER. THIS RESULT WAS REPORTED TO THE PHYSICIAN AS THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ELEVATED CA 19-9 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340134 ↗
• MalfunctionNov 27, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A DISCORDANT, ELEVATED ATELLICA IM CA19-9 RESULT FOR A PATIENT WHICH DISAGREED WITH THE CLINICAL PICTURES OF THE PATIENT AND WITH ALTERNATE METHOD TESTING. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN. 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 18210710 ↗
• MalfunctionNov 15, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A DISCORDANT, ELEVATED ATELLICA IM CA 19-9 RESULT FOR ONE PATIENT WHICH DISAGREED WITH ALTERNATE-METHOD TESTING AND CLINICAL INDICATIONS. CA 19-9 KIT LOT 528 WAS IN USE AT THE TIME. AN ELEVATED CA 19-9 RESULT WAS OBTAINED FOR A 66-YEAR-OLD MALE PATIENT. THIS RESULT WAS QUESTIONED BY THE PHYSICIAN, AS IT WAS CONSIDERED INCONSISTENT WITH THE PATIENT¿S CLINICAL PRESENTATION. A DIFFERENT SERUM SAMPLE FROM THE SAME PATIENT WAS TESTED AT ANOTHER SITE, USING A DIFFERENT METHOD, AND A MUCH LOWER RESULT WAS OBTAINED. THE LOWER RESULT WAS ACCEPTED 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 18142528 ↗
• MalfunctionOct 30, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED ATELLICA IM CA19-9 RESULT THAT WAS CONSIDERED DISCORDANT COMPARED TO THE HIGHER RESULT OF AN ALTERNATE TEST METHOD. THE INITIAL DISCORDANT RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. A CORRECTED REPORT WAS NOT ISSUED BY THE CUSTOMER. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA19-9 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18030274 ↗
• MalfunctionSep 26, 2023Low Test Results; Low Test Results

  A FALSELY DEPRESSED CA 19-9¿ (CA 19-9¿) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA IM 1600 INSTRUMENT. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULTS WERE HIGHER THAN THE ERRONEOUS RESULT. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CA 19-9¿ (CA 19-9¿) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816727 ↗
• MalfunctionSep 15, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED CA19-9 RESULT FOR ONE MALE PATIENT SAMPLE ON ATELLICA IM ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA IM ANALYZER WHICH PRODUCED RESULT SIMILAR TO THE INITIAL ELEVATED RESULT. THE SAMPLE WAS THEN MEASURED ON AN ALTERNATE TESTING METHOD AND THE RESULT WAS LOWER COMPARED TO THE ATELLICA IM RESULTS. A DIFFERENT SAMPLE FROM THE SAME PATIENT WAS TESTED ON ORIGINAL ATELLICA IM ANALYZER AND ALTERNATE ATELLICA IM ANALYZER. THE RESULTS WERE ELEVATED AS WELL. THE SAMPLE WAS TESTED ON A DIFFERENT ALTERNATE TESTING METHOD AND THE RESULT WAS LOWER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CA19-9 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17756872 ↗
• MalfunctionSep 15, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED CA19-9 RESULT FOR ONE MALE PATIENT SAMPLE ON ATELLICA IM ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA IM ANALYZER WHICH PRODUCED RESULT SIMILAR TO THE INITIAL ELEVATED RESULT. THE SAMPLE WAS THEN MEASURED ON AN ALTERNATE TESTING METHOD AND THE RESULT WAS LOWER COMPARED TO THE ATELLICA IM RESULTS. A DIFFERENT SAMPLE FROM THE SAME PATIENT WAS TESTED ON ORIGINAL ATELLICA IM ANALYZER AND ALTERNATE ATELLICA IM ANALYZER. THE RESULTS WERE ELEVATED AS WELL. THE SAMPLE WAS TESTED ON A DIFFERENT ALTERNATE TESTING METHOD AND THE RESULT WAS LOWER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CA19-9 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17756863 ↗

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-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-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-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-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