Alinity 08P4930Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380740131050), received between Apr 24, 2024 and Mar 20, 2026 — classified as 1 injury, 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

Recent adverse event reports

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

• MalfunctionMar 20, 2026Low Test Results

  THE CUSTOMER OBSERVED A FALSE DEPRESSED ALINITY I CA 125 II RESULT FOR A 70-YEAR-OLD FEMALE PATIENT THAT HAS BEEN DIAGNOSED WITH OVARIAN CANCER. THE FOLLOWING RESULTS WERE PROVIDED: (LAB REFERENCE RANGE FOR CA125 <35 KU/L) (B)(6) 2026, SID (B)(6) INITIAL RESULT = 10 KU/L, (B)(6) 2026 REPEAT RESULT = 899 KU/L, RESULT AFTER 1:10 DILUTION = 1008 KU/L . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647581 ↗
• InjuryApr 24, 2024High Test Results; High Test Results

  UPDATE: ADDITIONAL CLARIFYING INFORMATION WAS RECEIVED FROM THE CUSTOMER: THE ADDITIONAL TESTING AND SCANS WERE COMPLETED AFTER THE INITIAL RESULTS FROM (B)(6) 2024 WERE REPORTED. (B)(6) 2024: CERVICAL SMEAR FOR CYTOLOGY. (B)(6) 2024: G&C SCOPE. (B)(6) 2024: ENDOMETRIAL BIOPSY. THE DATES OF THE OTHER TESTING/SCANS ARE UNKNOWN. THE DETAILS OF THE FAMILY HISTORY OF CANCER IS UNKNOWN. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19176985 ↗