ARCHITECT 6C06-27Recalls & reported problems
Abbott Ireland Diagnostics · ARCHITECT Total PSA Reagent Kit · Class 2
Data updated Oct 13, 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 00380740008987), received between Dec 21, 2018 and Dec 20, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “High 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.
Most reported problems
Device problems
- High Test Results1
- Leak/Splash1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 20, 2019Leak/Splash; Leak/Splash
THE CUSTOMER REPORTED THAT A TECH WAS PLACING THE SEPTUM ON THE TOTAL PSA CONJUGATE BOTTLE WHEN HIS FINGER WENT THROUGH THE SEPTUM CAUSING THE SEPTUM TO SINK INTO THE VIAL AND FLUID TO SPLASH ON HIS EYELID. THE TECH THOROUGHLY RINSED HIS EYE, BUT DECLINED ANY FURTHER MEDICAL ATTENTION. THE TECH WAS WEARING A LAB COAT AND GLOVES, BUT NO EYE PROTECTION. THERE WAS NO ADVERSE IMPACT TO THE EMPLOYEE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9505678 ↗MalfunctionDec 21, 2018High Test Results; High Test Results
THE CUSTOMER OBSERVED A FALSELY ELEVATED TOTAL PSA RESULT ON THE ARCHITECT I1000SR AANLYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(4) INITIAL 32.64 NG/ML REPEATED 0.12, 0.14 AND 0.12. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8188954 ↗
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
- VITROS 1933027Ortho Clinical Diagnostics · PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS1 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 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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