Atellica IM PSA 10995663Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00630414599816), received between Oct 15, 2020 and Sep 14, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 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 9 most recent of 9 reports, 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 ↗
• 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 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 ↗
• 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 ↗
• MalfunctionOct 15, 2020High Test Results; High Test Results

  A CUSTOMER OBTAINED A DISCORDANT HIGH RESULT FOR A PATIENT SAMPLE USING ATELLICA IM PROSTATE SPECIFIC ANTIGEN (PSA). THE RESULT WAS REPORTED AND THE PHYSICIAN QUESTIONED THE RESULT. THE SAME SAMPLE WAS RETESTED ON THE SAME DAY USING 2 OTHER ATELLICA IM INSTRUMENTS AND RESULTS WERE LOWER THAN THE INITIAL ELEVATED RESULT. A NEW SAMPLE WAS COLLECTED FROM THE PATIENT AND WAS TESTED ON 2 OTHER ATELLICA IM INSTRUMENTS. THESE RESULTS WERE ALSO LOWER THAN THE INITIAL ELEVATED RESULT. A CORRECTED REPORT WAS PROVIDED TO THE PHYSICIAN, BUT IT IS UNKNOWN WHICH OF THE RETEST RESULTS WERE REPORTED. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, HIGH ATELLICA IM PSA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10682680 ↗

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)