Atellica IM PSA 10995662Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00630414599809), received between Apr 8, 2021 and Aug 24, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “High Test Results” (10 reports).

1 other recall cover devices cleared under the same FDA submission (P950021); 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.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Low Test Results

  The customer reported an observation of a falsely depressed Atellica IM Prostate Specific Antigen (PSA) result, which was discordant relative to repeat testing when using lot 347. The initial result was reported to the physician(s). The sample was reprocessed on the original analyzer. The repeat result recovered higher than the initial result and fitted the patient¿s history. The repeat result was reported as correct result 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 50401165 ↗
• MalfunctionOct 30, 2024High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED ATELLICA IM PSA LOT 340 RESULT ON A SERUM SAMPLE FROM A 58-YEAR-OLD MALE PATIENT (POST-PROSTATECTOMY). THE ELEVATED RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. THE CUSTOMER RETESTED THE SAMPLE ON THE SAME ATELLICA IM ANALYZER AND A DIFFERENT ATELLICA IM ANALYZER. BOTH RESULTS WERE LOWER, AS EXPECTED. A CORRECTED REPORT WAS ISSUED. THE PATIENT WAS ALSO SENT TO ANOTHER LABORATORY FOR ALTERNATE METHOD TESTING AND THE RESULT WAS LOW, AS EXPECTED. THERE ARE NO REPORTS OF ALTERED TREATMENT OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568027 ↗
• MalfunctionJan 8, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND REPEAT TESTING. AN INITIAL ELEVATED PSA RESULT WAS OBTAINED FOR A POST-PROSTATECTOMY PATIENT, AND NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS TESTED TWO MORE TIMES, USING THE SAME METHOD AND INSTRUMENT, AND BOTH REPEAT TESTS WERE LOWER (NEAR ZERO), AS EXPECTED. THE RESULT FROM THE THIRD TEST 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 18472338 ↗
• MalfunctionNov 28, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF REPRODUCIBLE DEPRESSED ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULTS FOR ONE PATIENT WHICH DISAGREED WITH AN ALTERNATE METHOD DURING A METHOD-COMPARISON STUDY. PSA LOT 331 WAS IN USE AT THE TIME. THE CUSTOMER HAS RECENTLY BEGUN USING THE ATELLICA IM PSA ASSAY, AND HAS BEEN COMPARING PATIENT RESULTS FROM THE ATELLICA IM PLATFORM AGAINST RESULTS GENERATED BY THEIR OTHER ESTABLISHED METHOD. FOR ONE PATIENT, ATELLICA IM PSA PRODUCED MUCH LOWER RESULTS THAN THE ALTERNATE METHOD. AN INITIAL LOW ATELLICA IM PSA RESULT WAS OBTAINED, AND SIMILAR RESULTS WERE PRODUCED WHEN THE SAMPLE WAS REPEAT-TESTED. THE INITIAL LOW RESULT WAS REPORTED TO THE PHYSICIAN, AND QUESTIONED. THE HIGHER RESULT PRODUCED BY THE ALTERNATE METHOD WAS CONSIDERED 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 18215639 ↗
• MalfunctionJan 6, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED DISCORDANT LOW RESULTS ON SAMPLES FROM THREE PATIENTS FOR THE ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) WHEN USING REAGENT LOT 321 AND SWITCHING FROM CALIBRATOR LOT CQ93 TO CQ96. THE SAMPLES WERE TESTED ON ATELLICA IM 1300 ANALYZER S/N: (B)(4). THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE NOT QUESTIONED. THE CUSTOMER STATED NO CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PSA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16111966 ↗
• MalfunctionJan 6, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED DISCORDANT LOW RESULTS ON SAMPLES FROM THREE PATIENTS FOR THE ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) WHEN USING REAGENT LOT 321 AND SWITCHING FROM CALIBRATOR LOT CQ93 TO CQ96. THE SAMPLES WERE TESTED ON ATELLICA IM 1300 ANALYZER S/N (B)(4). THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE NOT QUESTIONED. THE CUSTOMER STATED NO CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PSA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16111962 ↗
• MalfunctionApr 19, 2022High Test Results; High Test Results

  THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT DISCORDANT, ELEVATED ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULTS FROM A PATIENT THAT WERE CONSIDERED DISCORDANT COMPARED TO THE CLINICAL HISTORY OF THE PATIENT. THE PATIENT HAD PREVIOUSLY HAD SURGERY FOR PROSTATE CANCER. THE ELEVATED ATELLICA IM PSA RESULTS WERE REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ATELLICA IM PSA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141076 ↗
• MalfunctionApr 19, 2022High Test Results; High Test Results

  THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT DISCORDANT, ELEVATED ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULTS FROM A PATIENT THAT WERE CONSIDERED DISCORDANT COMPARED TO THE CLINICAL HISTORY OF THE PATIENT. THE PATIENT HAD PREVIOUSLY HAD SURGERY FOR PROSTATE CANCER. THE ELEVATED ATELLICA IM PSA RESULTS WERE REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ATELLICA IM PSA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141075 ↗
• MalfunctionApr 19, 2022High Test Results; High Test Results

  THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT DISCORDANT, ELEVATED ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULTS FROM A PATIENT THAT WERE CONSIDERED DISCORDANT COMPARED TO THE CLINICAL HISTORY OF THE PATIENT. THE PATIENT HAD PREVIOUSLY HAD SURGERY FOR PROSTATE CANCER. THE ELEVATED ATELLICA IM PSA RESULTS WERE REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ATELLICA IM PSA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141072 ↗
• MalfunctionApr 19, 2022High Test Results; High Test Results

  THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT A DISCORDANT, ELEVATED ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT FROM A PATIENT THAT WAS CONSIDERED DISCORDANT COMPARED TO THE CLINICAL HISTORY OF THE PATIENT. THE PATIENT HAD PREVIOUSLY HAD SURGERY FOR PROSTATE CANCER. THE ELEVATED ATELLICA IM PSA RESULT WAS REPORTED TO THE PHYSICIAN. A POSITRON EMISSION TOMOGRAPHY (PET) SCAN WAS PERFORMED ON THE PATIENT. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ATELLICA IM PSA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141065 ↗
• MalfunctionFeb 21, 2022Low Test Results; Low Test Results

  A DISCORDANT, LOW ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND QUESTIONED BY THE PHYSICIAN(S). THE SAMPLE WAS REPEATED WITH THE SAME INSTRUMENT, RESULTING HIGHER. THE SAME SAMPLE WAS RUN ON AN ALTERNATIVE ATELLICA IM INSTRUMENT, RESULTING HIGHER. THE INITIAL RESULT WAS REPORTED AND QUESTIONED. THE REPEATED HIGHER RESULTS WERE EQUIVALENT AND ALIGNED WITH THE CLINICAL HISTORY OF THE PATIENT. THE HIGHER PSA RESULTS WERE REPORTED AS THE CORRECTED RESULT TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, LOW ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13570461 ↗
• MalfunctionJan 20, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED A LOW ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT FOR A PATIENT SAMPLE ON (B)(6) 2021 THAT WAS CONSIDERED DISCORDANT WHEN COMPARED TO THE ELEVATED RESULT FROM AN ALTERNATE METHOD FROM (B)(6) 2021. THE CUSTOMER RECEIVED A COMPLAINT FROM THE PATIENT. THE SAME PATIENT SAMPLE WAS REPEATED ON A SECOND ATELLICA IM ON (B)(6) 2021 AND THE RESULT WAS SIMILAR. THE PREVIOUS PSA RESULT FROM (B)(6) 2021 FOR THIS PATIENT WAS REVIEWED. THE SAMPLE WAS TESTED ON THE ADVIA CENTAUR XP INSTRUMENT AND THE RESULT WAS SIMILAR TO THE ATELLICA IM PSA RESULTS (LOWER THAN THE ALTERNATE METHOD RESULT). THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PSA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13306498 ↗
• MalfunctionJan 20, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED A LOW ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT FOR A PATIENT SAMPLE ON 2021-12-14 THAT WAS CONSIDERED DISCORDANT WHEN COMPARED TO THE ELEVATED RESULT FROM AN ALTERNATE METHOD FROM 2021-03-31. THE CUSTOMER RECEIVED A COMPLAINT FROM THE PATIENT. THE SAME PATIENT SAMPLE WAS REPEATED ON A SECOND ATELLICA IM ON 2021-12-17 AND THE RESULT WAS SIMILAR. THE PREVIOUS PSA RESULT FROM 2021-02-02 FOR THIS PATIENT WAS REVIEWED. THE SAMPLE WAS TESTED ON THE ADVIA CENTAUR XP INSTRUMENT AND THE RESULT WAS SIMILAR TO THE ATELLICA IM PSA RESULTS (LOWER THAN THE ALTERNATE METHOD RESULT). THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PSA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13306491 ↗
• MalfunctionApr 26, 2021High Test Results; High Test Results

  A DISCORDANT, HIGH ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND QUESTIONED BY THE PHYSICIAN(S). THE PATIENT WAS REFERRED TO AN ALTERNATE LABORATORY FOR PSA TESTING, RESULTING LOWER. A NEW BLOOD DRAW SAMPLE WAS OBTAINED ON THE PATIENT, TESTED ON THE ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) ASSAY BY THE CUSTOMER, RESULTING LOW. THE CUSTOMER PERFORMED REPEAT PSA TESTING ON THE ORIGINAL PATIENT SAMPLE (30-MAR-2021), RUN ON THE SAME ATELLICA IM INSTRUMENT AND REAGENT LOT, RESULTING LOW. THE LOWER PSA RESULT WAS REPORTED AS THE CORRECTED RESULT TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, HIGH ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729072 ↗
• MalfunctionApr 13, 2021Low Test Results; Low Test Results

  A DISCORDANT, LOW ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND QUESTIONED BY THE PHYSICIAN(S). THE SAMPLE WAS REPEATED, RESULTING LOW. ANOTHER BLOOD DRAW WAS OBTAINED ON THE PATIENT. THE NEW SAMPLE WAS RUN ON THE SAME ATELLICA IM INSTRUMENT NEAT AND WITH DILUTION, RESULTING HIGHER. THE HIGHER PSA DILUTION RESULT WAS REPORTED AS THE CORRECTED RESULT TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, LOW ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11657864 ↗
• MalfunctionApr 13, 2021Low Test Results; Low Test Results

  A DISCORDANT, LOW ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND QUESTIONED BY THE PHYSICIAN(S). THE SAMPLE WAS REPEATED, RESULTING LOW. ANOTHER BLOOD DRAW WAS OBTAINED ON THE PATIENT. THE NEW SAMPLE WAS RUN ON THE SAME ATELLICA IM INSTRUMENT NEAT AND WITH DILUTION, RESULTING HIGHER. THE HIGHER PSA DILUTION RESULT WAS REPORTED AS THE CORRECTED RESULT TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, LOW ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11657862 ↗
• MalfunctionApr 8, 2021High Test Results; High Test Results

  A CUSTOMER OBSERVED A FALSELY ELEVATED ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT ON A SAMPLE FROM A POST-PROSTATECTOMY PATIENT. THE RESULT WAS DISCORDANT COMPARED TO TESTING WITH TWO ALTERNATE METHODS AND FROM THE PATIENT'S CLINICAL HISTORY. THE DISCORDANT ATELLICA IM PSA RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. HISTORICAL RESULTS FOR THIS PATIENT WERE REVIEWED AND TWO PREVIOUS ATELLICA IM PSA RESULTS WERE ALSO FOUND TO BE FALSELY ELEVATED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11638183 ↗
• MalfunctionApr 8, 2021High Test Results; High Test Results

  A CUSTOMER OBSERVED A FALSELY ELEVATED ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT ON A SAMPLE FROM A POST-PROSTATECTOMY PATIENT. THE RESULT WAS DISCORDANT COMPARED TO TESTING WITH TWO ALTERNATE METHODS AND FROM THE PATIENT'S CLINICAL HISTORY. THE DISCORDANT ATELLICA IM PSA RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. HISTORICAL RESULTS FOR THIS PATIENT WERE REVIEWED AND TWO PREVIOUS ATELLICA IM PSA RESULTS WERE ALSO FOUND TO BE FALSELY ELEVATED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11638137 ↗
• MalfunctionApr 8, 2021High Test Results; High Test Results

  A CUSTOMER OBSERVED A FALSELY ELEVATED ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT ON A SAMPLE FROM A POST-PROSTATECTOMY PATIENT. THE RESULT WAS DISCORDANT COMPARED TO TESTING WITH TWO ALTERNATE METHODS AND FROM THE PATIENT'S CLINICAL HISTORY. THE DISCORDANT ATELLICA IM PSA RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. HISTORICAL RESULTS FOR THIS PATIENT WERE REVIEWED AND TWO PREVIOUS ATELLICA IM PSA RESULTS WERE ALSO FOUND TO BE FALSELY ELEVATED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11638095 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P950021. One submission often covers many models, so check the product and lot details in each record.

• Z-2742-2016 · Aug 9, 2016 · Terminated
  ADVIA Centaur PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)