Atellica IM PSARecalls & reported problems across all models

We found 2 models of Atellica IM PSA by Siemens Healthcare Diagnostics Inc. in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Oct 15, 2020 and Sep 14, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “High Test Results” (16 reports).

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

Most reported Atellica IM PSA problems

Atellica IM PSA models

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

• Atellica IM PSA 10995662

  PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
  19 reports
• Atellica IM PSA 10995663

  PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
  9 reports

Recent Atellica IM PSA adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50761970 ↗
• 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 ↗
• MalfunctionJul 17, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING PSA LOT: 341. THE CUSTOMER NOTED A QUALITY CONTROL (QC) EXCURSION FOLLOWING A CHANGE OF PSA REAGENT PACK, WHERE QC LEVEL 1 WAS ABOVE EXPECTED RANGE. 10 SAMPLES WHICH HAD BEEN TESTED WITH THE AFFECTED REAGENT PACK WERE RE-TESTED ON ANOTHER ATELLICA IM SYSTEM WITH IN-RANGE QC. FOR THE PATIENT IN QUESTION, THE LOWER RESULT PRODUCED UPON REPEAT TESTING WAS 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 22529958 ↗
• MalfunctionJun 16, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A DISCORDANCE BETWEEN NEAT AND DILUTED ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) LOT 342 RESULTS ON ONE PATIENT SAMPLE. THE INITIAL NEAT RESULT OF 65.42 NG/ML WAS OBTAINED, AND THE CUSTOMER THEN TESTED THE SAMPLE BY DILUTION TO RULE OUT A POTENTIAL HOOK EFFECT. THE DILUTED RESULTS WERE HIGHER BY MORE THAN 15% THAN THE NEAT RESULT, BUT WITHIN THE ASSAY ANALYTICAL MEASURING RANGE (AMR). THE CUSTOMER REPORTED ONLY THE INITIAL RESULT AS CORRECT, AND IT WAS NOT QUESTIONED BY THE PHYSICIAN. 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 22213152 ↗
• 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 ↗
• MalfunctionOct 23, 2024High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) LOT: 337 RESULT THAT ON A PATIENT AFTER HAVING RECEIVED PROSTATIC CANCER TREATMENT. THE ATELLICA IM PSA RESULT WAS HIGHER THAN EXPECTED, INDICATING A POTENTIAL RELAPSE. THE SAMPLE WAS RETESTED WITH ALTERNATE TEST METHODS AND THE RESULTS OBTAINED WERE LOWER, IN LINE WITH THE PATIENT'S CLINICAL HISTORY AND WERE BELIEVED TO BE CORRECT. 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 20514851 ↗
• MalfunctionJul 24, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A DEPRESSED ATELLICA IM PROSTATE SPECIFIC ANTIGEN (PSA) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. AN INITIAL DEPRESSED PROSTATE SPECIFIC ANTIGEN (PSA) RESULT WAS OBTAINED FOR A 67-YEAR-OLD MALE PATIENT WHEN TESTED WITH PSA LOT 337. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON TWO DIFFERENT ATELLICA IM ANALYZERS, PRODUCING HIGHER RESULTS. THE HIGHER RESULTS WERE CONSIDERED CORRECT AS THEY WERE IN AGREEMENT WITH THE CLINICAL PICTURE FOR THE PATIENT, AND A CORRECTED REPORT WAS ISSUED BASED ON THE REPEAT TESTING. 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 19823343 ↗
• MalfunctionJan 17, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED A DISCORDANT DEPRESSED PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT ON A PATIENT SAMPLE ON ATELLICA IM 1600 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RETESTED ON THE SAME ATELLICA IM 1600 ANALYZER, AND THE RESULT WAS SIMILAR TO THE INITIAL RESULT. THIS SAMPLE WAS RETESTED ON TWO DIFFERENT ALTERNATE TESTING PLATFORMS AND THE RESULTS WERE HIGHER. THE HIGHER RESULT TESTED ON THE SECOND ALTERNATE METHOD WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS DISCORDANT DEPRESSED PROSTATE-SPECIFIC ANTIGEN (PSA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18530720 ↗
• 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 ↗
• MalfunctionAug 18, 2022High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSELY ELEVATED PROSTATE SPECIFIC ANTIGEN (PSA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA IM 1300 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO DID NOT QUESTION THE RESULT. PER LABORATORY PROTOCOL, THE SAMPLE WAS REPEATED THREE TIMES ON THE SAME INSTRUMENT A WEEK LATER AND THE REPEAT RESULTS RECOVERED LOWER THAN THE DISCORDANT RESULT AND AN AMENDED REPORT WAS PROVIDED TO THE PHYSICIAN(S). THE PATIENT UNDERWENT A FOLLOW UP POSITRON EMISSION TOMOGRAPHY (PET) SCAN. 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 15251167 ↗
• MalfunctionMay 7, 2022High Test Results; High Test Results

  A CUSTOMER OBTAINED A DISCORDANT (ELEVATED) ATELLICA IM (S/N (B)(4)) PROSTATE SPECIFIC ANTIGEN (PSA) RESULT FOR 3 PATIENT SAMPLES. THE SAMPLES WERE RETESTED ON A DIFFERENT ATELLICA IM INSTRUMENT (S/N (B)(4)) AND LOWER RESULTS WERE OBTAINED AS EXPECTED BASED ON NEGATIVE HISTORICAL RESULTS FROM 2020. THE CUSTOMER INDICATED THAT THE DISCORDANT RESULTS WERE NOT REPORTED TO PHYSICIAN(S). 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 14317173 ↗
• 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 ↗

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