Elecsys total PSARecalls & reported problems across all models

We found 5 models of Elecsys total PSA by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 60 adverse event reports in the FDA's MAUDE database, received between Aug 17, 2018 and Sep 28, 2026 — classified as 60 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (23 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 Elecsys total PSA problems

Elecsys total PSA models

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

• Elecsys total PSA 08791732190

  Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
  48 reports
• Elecsys Total PSA 09744860190

  Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
  4 reports
• Elecsys total PSA 07027966190

  Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
  3 reports
• Elecsys total PSA 08791686160

  Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
  3 reports
• Elecsys total PSA 08791716160

  Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
  2 reports

Recent Elecsys total PSA adverse event reports

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

• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917889 ↗
• MalfunctionSep 21, 2026Incorrect Measurement; Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847596 ↗
• MalfunctionSep 17, 2026Low Test Results

  There was an allegation of questionable Elecsys total PSA results that were lower than their free PSA results for 11 patient samples on a cobas e 801 analytical unit.Below are examples of three patient sample results that were provided by the customer.Sample 1 had an initial result of 0.044 ng/mL and a repeat result of 1.440 ng/mL.The sample had a free PSA result of 0.431 ng/mL.Sample 2 had an initial result of 0.021 ng/mL and a repeat result of 1.480 ng/mL.The sample had a free PSA result of 0.386 ng/mL.Sample 3 had an initial result of 0.019 ng/mL and a repeat result of 1.150 ng/mL.The sample had a free PSA result of 0.205 ng/mL.The repeat total PSA results were deemed correct.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806939 ↗
• MalfunctionAug 11, 2026High Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50206288 ↗
• MalfunctionAug 10, 2026Low Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50198725 ↗
• MalfunctionJul 29, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50073147 ↗
• MalfunctionApr 16, 2026Incorrect Measurement; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TOTAL PSA AND ELECSYS FREE PSA ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE TOTAL PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FREE PSA ASSAY. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AS THE RESULTS DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE SAMPLE RESULTED IN TOTAL PSA VALUES OF 0.10 NG/ML AND 0.0972 NG/ML. THE SAMPLE RESULTED IN FREE PSA VALUES OF 0.535 NG/ML AND 0.530 NG/ML. THE SAMPLE WAS TREATED WITH POLYETHYLENE GLYCOL (PEG) AND THE TESTS HAD A LOW RECOVERY RATE. DILUTION STUDIES SHOWED ABNORMAL RECOVERY WITH THE HIGHER DILUTION RATIOS. NO SPECIFIC DATA WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24898939 ↗
• MalfunctionMar 30, 2026High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH TOTAL PSA ELECSYS E2G ASSAY ON A COBAS E 801 ANALYTICAL UNIT, NOT MATCHING THE EXPECTED RESULTS. INITIAL RESULT: <0.014 NG/ML. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN AS 0.014 NG/ML (NOT <0.014 NG/ML), AND ACCOMPANIED BY "ERROR 27". THE RESULT OF 0.014 NG/ML WAS HIGHER THAN THE LABORATORY'S RULE OF 0.006 NG/ML AND WAS SENT TO THE PHYSICIAN. IT WAS CONSIDERED INACCURATE AS THE PHYSICIAN AND THE PATIENT EXPECTED A RESULT LOWER THAN THE REPORTABLE RANGE OF <0.006 NG/ML. THE SAMPLE WAS THEN REPEATED ON A DIFFERENT INSTRUMENT AT THE CUSTOMER'S SITE WITH A LABORATORY-DEVELOPED TEST WHOSE VERSION HAD NOT BEEN UPDATED, AND THE REPEAT RESULT WAS <0.006 NG/ML (ACCOMPANIED BY A DATA FLAG). THE RESULT OF <0.014 NG/ML USING THE UPDATED LABORATORY'S RULE WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715641 ↗
• MalfunctionFeb 25, 2026Incorrect Measurement

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TOTAL PSA ASSAY AND ELECSYS FREE PSA ASSAY RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH IS FOR THE ELECSYS TOTAL PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS FREE PSA ASSAY. THE INITIAL FREE PSA RESULT IS 0.243 NG/ML. THE INITIAL TOTAL PSA RESULT IS 0.0368 NG/ML. THE REPEAT RESULTS WERE CONSISTENT WITH THE INITIAL RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445677 ↗
• MalfunctionFeb 24, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH TOTAL PSA ELECSYS E2G RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 100 G/L. THE REPEAT RESULT USING A DILUTION WAS 5000 G/L WITH A DATA FLAG. ON (B)(6) 2026, THE SAMPLE WAS REPEATED USING PEG, AND THE RESULT WAS 100 G/L. THE PHYSICIAN BELIEVED THAT THIS WAS NOT RELIABLE, ESPECIALLY AS THE PATIENT DIDN'T HAVE ANY SYMPTOMS AND WAS BEING TESTED AS A ROUTINE CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24427941 ↗
• MalfunctionFeb 4, 2026Incorrect Measurement

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOTAL PSA RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. THIS MEDWATCH WILL APPLY TO THE ELECSYS TOTAL PSA (TPSA) ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1 PATIENT INDENTIFIER (B)(6) FOR THE INFORMATION RELATED TO THE ELECSYS FREE PSA (FPSA) ASSAY. THE INITIAL TPSA RESULT WAS 0.192 NG/ML, AND THE FPSA RESULT WAS 9.96 NG/ML. THE TPSA RESULT ON A SIEMENS INSTRUMENT WAS 6.71 NG/ML, AND THE FPSA RESULT WAS 0.04 NG/ML. THE TPSA RESULT ON (B)(6) 2026 ON THE E 801 WAS 0.174 NG/ML, AND THE FPSA RESULT WAS 10.1 NG/ML. THE TPSA RESULT ON (B)(6) 2026 ON THE E 602 WAS 0.160 NG/ML, AND THE FPSA RESULT WAS 10.58 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260460 ↗
• MalfunctionJan 20, 2026Incorrect Measurement; Output Problem

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS FREE PSA (FREE PSA) AND ELECSYS TOTAL PSA (TOTAL PSA) ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER TOTAL PSA. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FREE PSA RESULTS. THE INITIAL TOTAL PSA RESULT WAS 0.21 NG/ML. THE INITIAL FREE PSA RESULT WAS 10.50 NG/ML. THE REPEAT FREE PSA RESULT WAS 11.70 NG/ML. A NEW SAMPLE WAS OBTAINED, AND THE TOTAL PSA RESULT WAS 0.13 NG/ML. THE FREE PSA RESULT WAS 8.50 NG/ML. THE NEW SAMPLE WAS REPEATED BY THE SIEMENS METHOD, AND THE TOTAL PSA RESULT WAS 6.60 NG/ML, AND THE FREE PSA RESULT WAS 0.05 NG/ML. THE CUSTOMER SUSPECTS AN INTERFERENCE AFFECTING THE ROCHE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121118 ↗
• MalfunctionDec 17, 2025Incorrect Measurement; Non Reproducible Results; Incorrect Measurement; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLES TESTED WITH ELECSYS TOTAL PSA ASSAY AND ELECSYS FREE PSA ASSAY ON A COBAS 8000 E 801 MODULE. THIS MEDWATCH WILL APPLY TO THE ELECSYS TOTAL PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS FREE PSA ASSAY. THE FREE PSA (FPSA) VALUE WAS GREATER THAN THE TOTAL PSA (TPSA) VALUE. THE TPSA RESULTS WERE 0.0294 NG/ML (ACCOMPANIED BY A DATA FLAG), 0.0229 NG/ML (ACCOMPANIED BY A DATA FLAG), AND 0.563 NG/ML. THE FPSA RESULTS WERE 0.584 NG/ML, 0.853 NG/ML, AND 0.0413 NG/ML (ACCOMPANIED BY A DATA FLAG).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829748 ↗
• MalfunctionDec 11, 2025Incorrect Measurement; Unable to Obtain Readings; Incorrect Measurement; Unable to Obtain Readings

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TOTAL PSA AND ELECSYS FREE PSA ON TWO COBAS E 801 ANALYTICAL UNIT ANALYZERS. THE FREE PSA VALUE WAS LARGER THAN THE TOTAL PSA VALUE. THIS MEDWATCH WILL APPLY TO THE TOTAL PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FREE PSA ASSAY. THE SAMPLE WAS TESTED THREE TIMES ON THE FIRST E801 ANALYZER, RESULTING IN THE FOLLOWING VALUES: TOTAL PSA = 0.172 NG/ML, 0.172 NG/ML, AND 0.174 NG/ML, FREE PSA = 0.203 NG/ML, 0.211 NG/ML, AND 0.195 NG/ML. THE SAMPLE WAS TESTED ON THE SECOND E801 ANALYZER, RESULTING IN THE FOLLOWING VALUES: TOTAL PSA = 0.185 NG/ML, FREE PSA = 0.191 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780728 ↗
• MalfunctionDec 5, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS TOTAL PSA ASSAY ON A COBAS E 801 MODULE, WHICH DID NOT MATCH THE PATIENT'S CLINICAL CONDITION. INITIAL RESULT: 0.07 NG/ML. THE INITIAL RESULT ALSO DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS OF <0.006 NG/ML, AND THE SAMPLE WAS THEN REPEATED ON (B)(6) 2025. REPEAT RESULT: <0.006 NG/ML. THE REPEAT RESULT WAS WITH THE EXPECTED VALUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729555 ↗

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