VITROS 1933027Recalls & reported problems
Ortho Clinical Diagnostics · VITROS Immunodiagnostic Products PSA Calibrators · Class 2
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 10758750000319), received between Oct 5, 2023 and Oct 5, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Test Results” (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.
Reports received per month
Most reported problems
Device problems
- Low Test Results1
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.
MalfunctionOct 5, 2023Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS PROSTATIC SPECIFIC ANTIGEN (PSA) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD LOT 85330 QUALITY CONTROL FLUID AND A SINGLE LEVEL OF NON-VITROS FUJI REBIO TUMOR MARKER CONTROLS LOT 49820 USING VITROS PSA REAGENT LOT 4340 TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE BIORAD RESULTS WERE LOWER THAN EXPECTED WHEN COMPARED TO THE CUSTOMER¿S BASELINE MEAN AND THE FUJI REBIO RESULT WAS LOWER THAN EXPECTED WHEN COMPARED TO THE PACKAGE INSERT MEAN. BIORAD LEVEL 2 VITROS PSA RESULTS OF 1.43 AND 1.45 NG/ML VS. THE EXPECTED PSA RESULT OF 1.98 NG/ML FUJI REBIO LEVEL 1 VITROS PSA RESULT OF 2.31 NG/ML VS. THE EXPECTED PSA RESULT OF 3.21 NG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL SAMPLES. THE CUSTOMER MADE NO INDICATION THAT PATIENT SAMPLES WERE AFFECTED HOWEVER, THE INVESTIGATION CANNOT CONFIRM PATIENT RESULTS WOULD NOT BE AFFECTED IN THE EVENT WERE TO RECUR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17882022 ↗
Other PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS devices
- Atellica IM PSA 10995662Siemens Healthcare Diagnostics Inc. · PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS19 reports
- ADVIA Centaur® PSA 10310292Siemens Healthcare Diagnostics Inc. · Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers9 reports
- Atellica IM PSA 10995663Siemens Healthcare Diagnostics Inc. · PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS9 reports
- ADVIA Centaur® PSA 10310293Siemens Healthcare Diagnostics Inc. · Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers5 reports
- VITROS 6801756Ortho Clinical Diagnostics · PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS5 reports
- Elecsys free PSA 09744908190Roche Diagnostics GmbH · PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS2 reports
- ARCHITECT 6C06-27Abbott Ireland Diagnostics · PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS2 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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