Elecsys free PSARecalls & reported problems across all models

We found 5 models of Elecsys free PSA by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Aug 17, 2018 and Sep 21, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (20 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 free PSA problems

Elecsys free PSA models

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

• Elecsys free PSA 08828610190

  Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
  25 reports
• Elecsys free PSA 07027320190

  Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
  2 reports
• Elecsys free PSA 03289788160

  Test,Prostate Specific Antigen,Free,(Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
  2 reports
• Elecsys free PSA 09744908190

  PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
  2 reports
• Elecsys free PSA 08828601160

  Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
  1 report

Recent Elecsys free PSA adverse event reports

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

• MalfunctionSep 21, 2026Incorrect Measurement; Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847598 ↗
• MalfunctionFeb 4, 2026Incorrect Measurement

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FREE PSA RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. THIS MEDWATCH WILL APPLY TO THE ELECSYS FREE PSA (FPSA) ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1 PATIENT INDENTIFIER (B)(6) FOR THE INFORMATION RELATED TO THE ELECSYS TOTAL PSA (TPSA) 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 24260447 ↗
• 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 FREE PSA. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TOTAL 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 24121123 ↗
• 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 FREE PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER: (B)(6) FOR INFORMATION RELATED TO THE ELECSYS TOTAL 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 23830048 ↗
• 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 FREE PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TOTAL 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 23780709 ↗
• MalfunctionNov 24, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOTAL PSA AND ELECSYS FREE PSA RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT THAT DID NOT AGREE WITH THE CLINICAL STATUS OF THE PATIENT. AN INTERFERENCE WAS SUSPECTED. THIS MEDWATCH IS FOR THE FREE PSA ASSAY. REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE TOTAL PSA ASSAY. THE PATIENT HAD BEEN MONITORING HIS RESULTS SINCE 2015. THE RESULTS HAVE FLUCTUATED OVER THE YEARS, BUT THE TOTAL PSA RESULTS WERE AROUND 1.2-1.5 NG/ML, AND THE FREE PSA RESULTS WERE AROUND 0.18-0.2 NG/ML. TWO YEARS AGO, THE PATIENT HAD AN MRI, WHICH SHOWED NO CHANGES. WITHIN THE PAST MONTH, AN MRI REVEALED A LESION, AND THE BIOPSY CONFIRMED THE PRESENCE OF A MALIGNANT TUMOR. THE DOCTORS BELIEVE THE RESULTS SHOULD HAVE BEEN SIGNIFICANTLY HIGHER BASED ON THE PATIENT'S MRI AND BIOPSY. THE PATIENT HAD A TOTAL PSA PERFORMED AT ANOTHER LABORATORY, USING ABBOTT TECHNOLOGY, AND THE RESULT WAS 9 NG/ML. THE FOLLOWING DAY, THE TOTAL PSA RESULT USING THE COBAS E 801 ANALYTICAL UNIT WAS 1.79 NG/ML. A NEW SAMPLE WAS TAKEN FROM THE PATIENT, AND THE TOTAL PSA RESULT WAS 1.87 NG/ML, AND THE FREE PSA RESULT WAS 1.17 NG/ML. USING A COBAS PURE AT ANOTHER LABORATORY, THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630312 ↗
• MalfunctionNov 7, 2025Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test 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 FREE PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TOTAL PSA ASSAY. TOTAL PSA: INITIAL RESULT: 0.0290 NG/ML. REPEAT RESULT: 0.0264 NG/ML. FREE PSA: INITIAL RESULT: 0.352 NG/ML. REPEAT RESULT: 0.351 NG/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY, AS THE INITIAL RESULTS DID NOT MATCH THE PATIENT'S CLINICAL PRESENTATION. THE CUSTOMER ALLEGED THAT THE FREE PSA RESULTS ARE HIGHER THAN THE TOTAL PSA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500804 ↗
• MalfunctionAug 26, 2025Output Problem; Output Problem

  THE INITIAL REPORTER COMPLAINED OF HIGH RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR ELECSYS FREE PSA (FREE PSA) ON A COBAS E 801 ANALYTICAL UNIT. THE FREE PSA RESULTS WERE HIGHER THAN THE ELECSYS TOTAL PSA (TOTAL PSA) RESULTS. THIS MEDWATCH WILL COVER FREE PSA. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TOTAL PSA RESULTS. EXAMPLES OF QUESTIONABLE RESULTS WERE PROVIDED FOR 3 PATIENT SAMPLES. PATIENT 1 FREE PSA RESULT WAS 0.0176 NG/ML. THE TOTAL PSA RESULT WAS 0.0073 NG/ML. PATIENT 2 FREE PSA RESULT WAS 0.0166 NG/ML. THE TOTAL PSA RESULT WAS 0.006 NG/ML WITH A DATA FLAG. ON (B)(6) 2025 PATIENT 3 FREE PSA RESULT WAS 0.0203 NG/ML. THE TOTAL PSA RESULT WAS 0.0110 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893304 ↗
• MalfunctionAug 14, 2025Incorrect Measurement; Incorrect Measurement

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOTAL PSA AND ELECSYS FREE PSA RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 402 ANALYTICAL UNIT. THE ELECSYS TOTAL PSA AND ELECSYS FREE PSA INITIAL RESULTS WERE BOTH MARKED BY "SAMP.C" ALARMS. THE SAMPLE WAS REPEATED. THE ELECSYS FREE PSA RESULT WAS 0.922 NG/ML. THE ELECSYS TOTAL PSA RESULT WAS 0.497 NG/ML. THE TECHNICIAN OBSERVED RED DOTS IN THE SERUM SAMPLE. ON (B)(6) 2025, AN ALIQUOT OF THE SAMPLE WAS RECENTRIFUGED AND TESTED. THE ELECSYS FREE PSA RESULT WAS 0.187 NG/ML. THE ELECSYS TOTAL PSA RESULT WAS 0.482 NG/ML. THIS MEDWATCH WILL APPLY TO THE ELECSYS FREE PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER: (B)(6) FOR INFORMATION RELATED TO THE ELECSYS TOTAL PSA ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22805861 ↗
• MalfunctionJul 28, 2025Output Problem; Output Problem

  THERE WAS AN ALLEGATION OF 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 ELECSYS FREE PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS TOTAL PSA ASSAY. THE FREE PSA (FPSA) VALUE WAS GREATER THAN THE TOTAL PSA (TPSA) VALUE. THE TPSA RESULTS WERE 1.22 AND 1.33 NG/ML. THE FPSA RESULTS WERE 1.98 AND 1.87 NG/ML. THE SAME SAMPLE WAS REPEATED AFTER RECALIBRATION AND ON ANOTHER MODULE. THE RESULTS REMAINED THE SAME; HOWEVER, THE ACTUAL VALUES WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628882 ↗
• MalfunctionJul 25, 2025Incorrect Measurement; Non Reproducible Results; Incorrect Measurement; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 2 SAMPLES FROM THE SAME PATIENT TESTED WITH ELECSYS TOTAL PROSTATE SPECIFIC ANTIGEN (TOTAL PSA) ASSAY AND ELECSYS FREE PROSTATE SPECIFIC ANTIGEN (FREE PSA) ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE FREE PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TOTAL PSA ASSAY. SAMPLE 1: TOTAL PSA: INITIAL RESULT: 0.0821 NG/ML. FREE PSA: INITIAL RESULT: 1.99 NG/ML. THIS FREE PSA RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE FREE PSA RESULT WAS GREATER THAN THE TOTAL PSA RESULT, PROMPTING THE REPEAT OF THE SAMPLE THE NEXT DAY. THE REPEAT RESULTS WERE IDENTICAL TO THE INITIAL RESULTS. ON (B)(6) 2025, A NEW BLOOD SAMPLE (SAMPLE 2) WAS TAKEN FROM THE PATIENT AND TESTED: TOTAL PSA RESULT: 0.0807 NG/ML. FREE PSA RESULT: 1.99 NG/ML. OTHER TOTAL PSA AND FREE PSA TESTS WERE PERFORMED AT A DIFFERENT SERVICE LABORATORY USING SIEMENS ATELLICA SOLUTION, RESULTING IN THE FOLLOWING: TOTAL PSA RESULT: 1.220 UG/L. FREE PSA RESULT: 0.023 UG/L. THESE RESULTS WERE DEEMED TO BE CORRECT. IT IS NOT KNOWN IF SAMPLE 2 WAS REPEATED ON SIEMENS TESTING OR IF ANOTHER NEW S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22612925 ↗
• MalfunctionJun 13, 2025Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS FREE PSA RESULT FROM THE COBAS E 402 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE ELECSYS FREE PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1 PATIENT INDENTIFIER (B)(6) FOR THE INFORMATION RELATED TO THE ELECSYS TOTAL PSA ASSAY. THE INITIAL FREE PSA RESULT WAS 0.275 NG/ML, AND A TOTAL PSA FROM A COBAS E 411 WITH A RESULT OF 0.063 NG/ML. THE SAMPLE WAS SENT TO ANOTHER LAB AND RAN ON ANOTHER COBAS E 411 ANALYZER WITH THE SAME RESULTS OF FREE PSA GREATER THAN TOTAL PSA. THE CUSTOMER THEN RAN THE SAMPLE ON AN ABBOTT PLATFORM, AND THE FREE PSA RESULT WAS 0.04 NG/ML, AND THE TOTAL PSA RESULT WAS 0.08 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202252 ↗
• MalfunctionMay 20, 2025Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TOTAL PSA (TOTAL PSA) ASSAY AND ELECSYS FREE PSA (FREE PSA) RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PURE E 402 ANALYTICAL UNIT. THIS MEDWATCH IS FOR THE ELECSYS FREE PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS TOTAL PSA (TOTAL PSA) ASSAY. TOTAL PSA THE INITIAL RESULT FROM THE ANALYZER WAS 0.172 NG/ML. THE REPEAT RESULT FROM THE COBAS E 801 ANALYZER WAS 0.186 NG/ML. THE REPEAT RESULT FROM A REFERRAL LABORATORY USING THE CHEMILUMINESCENT IMMUNOASSAY (CLIA) LABORATORY METHOD WAS 0.36 NG/ML. FREE PSA THE INITIAL RESULT FROM THE ANALYZER WAS 0.443 NG/ML. THE REPEAT RESULT FROM THE COBAS E 801 ANALYZER WAS 0.447 NG/ML. THE REPEAT RESULT FROM A REFERRAL LABORATORY USING THE CLIA LABORATORY METHOD WAS 0.10 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22051696 ↗
• MalfunctionMay 15, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TOTAL PSA (TOTAL PSA) ASSAY AND FREE PSA ASSAY RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH IS FOR THE ELECSYS FREEL PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS TOTAL PSA (TOTAL PSA) ASSAY. TOTAL PSA: THE INITIAL RESULT FROM THE ANALYZER WAS 0.282 NG/ML. THE REPEAT RESULT FROM A COMPETITOR ANALYZER WAS 2.183 NG/ML. THE PATIENT SAMPLE WAS DILUTED WITH INCREASING AMOUNTS OF NEGATIVE SERUM, AS THE RESULT WAS LOWER THAN THE LEVEL OF DETECTION (LOD). THE REPEAT RESULT AT 1:2 DILUTION WAS 0.143 NG/ML. THE REPEAT RESULT AT 1:4 DILUTION WAS 0.0787 NG/ML. THE REPEAT RESULT AT 1:8 DILUTION WAS 0.0418 NG/ML. FREE PSA: THE INITIAL RESULT FROM THE ANALYZER WAS 1.21NG/ML. THE REPEAT RESULT FROM A COMPETITOR ANALYZER WAS 1.403 NG/ML. THE PATIENT SAMPLE WAS DILUTED WITH INCREASING AMOUNTS OF NEGATIVE SERUM, AS THE RESULT WAS LOWER THAN THE LEVEL OF DETECTION (LOD): THE REPEAT RESULT AT 1:2 DILUTION WAS 0.588 NG/ML. THE REPEAT RESULT AT 1:4 DILUTION WAS 0.311 NG/ML. THE REPEAT RESULT AT 1:8 DILUTION WAS 0.156 NG/ML. THE INITIAL RESULTS WERE NOT REPORTED OUTSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026606 ↗
• MalfunctionFeb 11, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS FREE PSA (FREE PSA) ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1 INITIAL RESULT WAS 1.01 NG/ML. THE REPEAT RESULT WAS 0.364 NG/ML. PATIENT 2 INITIAL RESULT WAS 1.88 NG/ML. THE REPEAT RESULT WAS 0.451 NG/ML. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354459 ↗

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