Elecsys tPSA 04641655160Recalls & reported problems
Roche Diagnostics GmbH · tPSA reagent, 100 Test-Kit · Class 3
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613336154366), received between Dec 22, 2021 and Dec 22, 2021 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Incorrect Measurement1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 TOTAL PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FREE 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 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 13059974 ↗
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- Dimension® clinical chemistry system TPSA Flex® reagent cartridge 10444889Siemens Healthcare Diagnostics Inc. · Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer12 reports
- Elecsys Total PSA 09744860190Roche Diagnostics GmbH · Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer4 reports
- Elecsys total PSA 08791686160Roche Diagnostics GmbH · Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer3 reports
- Elecsys total PSA 07027966190Roche Diagnostics GmbH · Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer3 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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