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Alinity 07P9231Recalls & reported problems

Abbott Ireland Diagnostics · Alinity i Total PSA Reagent Kit 1200 Tests · Class 3

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 00380740158323), received between Feb 11, 2020 and Feb 11, 2020 — classified as 1 malfunction.

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

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 11, 2020High Test Results; High Test Results

    THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I TOTAL PSA RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2019 SID (B)(4) = 4.96UG/L (DIAGNOSTIC RANGE 0.0 - 3.9UG/L). THE PATIENT IS BEING MONITORED POST PROSTATE CANCER TREATMENT AND HIS PREVIOUS RESULTS WERE LESS THAN 0.01UG/L. REPEAT SAMPLE ON (B)(6) 2020 = LESS THAN 0.01UG/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9695211 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.