Alinity 07P9020Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380740130817), received between May 5, 2021 and Mar 10, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I AFP RESULTS FOR ONE PATIENT. THE PATIENT WAS REPEATED ON MULTIPLE INSTRUMENTS WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: (AFP REFERENCE VALUE AT FACILITY: 0.9-8.8 NG/ML) SID (B)(6) INITIAL ALINITY AFP RESULT PROCESSED ON (B)(6) 2025 ON SERIAL NUMBER (B)(6) = 39.50 NG/ML RETESTED ON (B)(6) 2025 ON (B)(6) = <2.0 NG/ML AND ON (B)(6) = <2.00 NG/ML NEW SPECIMEN SAME PATIENT SID (B)(6) PROCESSED ON (B)(6) 2025 RESULTS FROM ALINITY I INSTRUMENT SERIAL NUMBER (B)(6) = <2.00 NG/ML AND <2.00 NG/ML AND PROCESSED ON (B)(6) = <2.0 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561728 ↗
• MalfunctionMar 3, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I AFP GENERATED FROM ALINITY I PROCESSING MODULE AND PROVIDED THE FOLLOWING DATA: CUSTOMER NORMAL RANGE: 0.9 - 8.8 UG/L. (B)(6): SAMPLE ID: (B)(6), (PATIENT FROM HEALTH SCREENING). 1ST RUN (B)(6): 13.4, 2ND RUN (B)(6): 2.6, 3RD RUN (B)(6): 2.6. ON (B)(6): SAMPLE ID: (B)(6), (PATIENT FROM ENT CLINIC). 1ST RUN (B)(6): 11.7, 2ND RUN (B)(6): 8.0, 3RD RUN (B)(6): 7.4. ON (B)(6): SAMPLE ID: (B)(6), (PATIENT FROM GASTROINTESTINAL CLINIC). 1ST RUN (B)(6): 26. 2ND RUN (B)(6): 2.9. 3RD RUN (B)(6): 3.3. NO OTHER PATIENT INFORMATION WAS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21509097 ↗
• MalfunctionMay 5, 2021Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED ALINITY I AFP RESULT ON A PATIENT. RESULTS PROVIDED: (B)(6) 2021 SID (B)(6) = 13 / > 1660 / > 1660 / X10 DILUTION = 5823 / 5800 IU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778278 ↗