Alinity 08P4920Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380740131043), received between Sep 10, 2019 and Mar 31, 2026 — 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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED ALINITY I CA 125 II RESULT FOR A 75 YEAR OLD FEMALE PATIENT, WHICH WAS INCONSISTENT WITH THE PATIENT¿S HISTORICAL RESULTS. IT IS UNKNOWN WHETHER THE PATIENT HAS EPITHELIAL OVARIAN CANCER. THE PATIENT QUESTIONED THE RESULT, AND THE SAMPLE WAS REPEATED, YIELDING HIGHER RESULTS. THE FOLLOWING DATA WERE PROVIDED: SID (B)(6): (B)(6) 2026 INITIAL RESULT = 16.8 U/ML (NEGATIVE). REPEAT RESULT = >1000 U/ML. REPEAT RESULT (1:10 DILUTION) = >10,000 U/ML. HISTORICAL RESULTS: (B)(6) 2025 RESULT = 8998.0 U/ML (POSITIVE). (B)(6) 2025 RESULT = 4001.0 U/ML (POSITIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746116 ↗
• MalfunctionSep 10, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA125 RESULT ON ONE PATIENT. RESULTS PROVIDED: (B)(6) 2019 = 136 U/ML; NEW SAMPLE TESTED AT ANOTHER LABORATORY (METHOD UNKNOWN) = 16; NEW SAMPLE FROM OTHER LABORATORY PROCESSED ON THIS ALINITY = 16 U/ML. IT IS UNKNOWN IF THE PATIENT IS DIAGNOSED WITH OVARIAN CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8983835 ↗