Alinity 08P3221Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380740155919), received between Mar 23, 2020 and Feb 13, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY CA 19-9XR RESULT GENERATED ON THE ALINITY I AM PROCESSING MODULE FOR ONE PATIENT WITH A HISTORY OF PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025, SID (B)(6): INITIAL CA 19-9 RESULT = > 4000 U/ML. REPEAT CA 19-9 RESULT ON ANOTHER ALINITY I ((B)(6)) = 4438.19 U/ML (REPORTED TO THE DOCTOR). DUE TO THE ELEVATED CA 19-9 RESULT, THE PATIENT¿S SURGERY WAS CANCELLED. IT IS NOT KNOWN WHAT TYPE OF SURGERY WAS CANCELLED AND IF THE SURGERY WAS RESCHEDULED. THE CUSTOMER STATED THAT THE PATIENT WAS TESTED AT A NEIGHBORING FACILITY ((B)(6)) ON (B)(6) 2025 AND OBTAINED A CA 19-9 RESULT OF 600. THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21380671 ↗
• MalfunctionJul 2, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I CA 19-9XR RESULT FOR AN 83-YEAR-OLD FEMALE PATIENT WHO UNDERGOES REGULAR TESTING EVERY SIX MONTHS OR SO. DUE TO THE ELEVATED ALINITY I CA 19-9XR RESULT, THE FOLLOW-UP TESTING PERIOD WAS REDUCED, AND THE PATIENT WAS TESTED AGAIN ON (B)(6) 2023 WHICH SHOWED A LOWER RESULT. IT IS UNKNOWN IF THE PATIENT WAS DIAGNOSED WITH PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED: CA 19-9XR RESULT (2 MONTHS PRIOR) = 90 U/ML. FOLLOW-UP RESULT = (B)(6) 2023 CA 19-9XR RESULT = 17 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17244384 ↗
• MalfunctionMar 14, 2023High Test Results; High Test Results

  UPDATE: RECEIVED ADDITIONAL INFORMATION FROM CUSTOMER ON 27 MAR 2023. CUSTOMER STATED THEY PERFORMED A HETEROPHILE BLOCKING TUBE TEST FOR THE SAMPLE AND GENERATED THE SAME RESULT OF > 96,000 U/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538843 ↗
• MalfunctionMar 23, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED CA19-9 RESULT ON THE ALINITY ANALYZER. THE FOLLOWING DATA WAS PROVIDED: CASE 2 (B)(6): MALE DOB (B)(6) 1969 DIAGNOSED WITH AN UNKNOWN TYPE OF CANCER: INITIAL 812.92, REPEAT 1717.82 U/ML (111% SHIFT). THERE WAS NO NEGATIVE IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9865054 ↗