Elecsys free PSA 03289788160Recalls & reported problems
Roche Diagnostics GmbH · fPSA reagent · Class 3
All models of Elecsys free PSA (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336154397), received between Dec 22, 2021 and Feb 15, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (1 report).
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
Device problems
- Incorrect Measurement1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Low Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 15, 2022Low Test Results; Low Test Results
THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TOTAL PSA AND ELECSYS FREE PSA RESULTS FOR ONE PATIENT SAMPLE WITH A COBAS E 801 MODULE SERIAL NUMBER UNKNOWN. THE FREE PSA VALUE WAS GREATER THAN THE TOTAL PSA VALUE. THE TOTAL PSA RESULT WAS 0.19 NG/ML. THE FREE PSA RESULT WAS 0.25 NG/ML. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH IS FOR FREE PSA. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE TOTAL PSA ASSAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13537388 ↗MalfunctionDec 22, 2021Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings
THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TOTAL PSA IMMUNOASSAY AND ELECSYS FREE PSA IMMUNOASSAY RESULTS FOR ONE PATIENT SAMPLE TESTED ON THE COBAS E 411 IMMUNOASSAY ANALYZER WITH SERIAL NUMBER (B)(4). THIS MEDWATCH WILL APPLY TO THE FREE PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TOTAL PSA ASSAY. THE REPORTER RERAN A PREVIOUS TOTAL PSA SAMPLE AND INCLUDED THE FREE PSA IN THE RUN. THE FREE PSA RESULT WAS NOTED TO BE HIGHER THAN THE TOTAL PSA RESULT. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE TOTAL PSA RESULT WAS 0.024 NG/ML. THE FREE PSA WAS 0.5 NG/ML.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13059980 ↗
Other Test,Prostate Specific Antigen,Free,(Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions devices
- Alinity 07P9321Abbott Ireland Diagnostics · Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions1 recall0 reports
- Elecsys free PSA 08828610190Roche Diagnostics GmbH · Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions25 reports
- Dimension Vista® System FPSA Flex® Reagent Cartridge 10445091Siemens Healthcare Diagnostics Inc. · Test,Prostate Specific Antigen,Free,(Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions3 reports
- Elecsys free PSA 07027320190Roche Diagnostics GmbH · Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions2 reports
- Elecsys free PSA 08828601160Roche Diagnostics GmbH · Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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