Alinity 07P9030Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380740130824), received between May 31, 2023 and Dec 9, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “High Test Results” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I AFP RESULTS GENERATED BY THE ALINITY I PROCESSING MODULE FOR THREE PATIENTS. NO INFORMATION WAS AVAILABLE REGARDING THE PATIENTS¿ DIAGNOSES. THE SAMPLES WERE REPEATED, AND LOWER RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: =8.1 G/L. SID (B)(6) (59-YEAR-OLD MALE): (B)(6) 2025 ALINITY I AFP INITIAL RESULT = 42.4 G/L, REPEAT RESULT = 2.9 G/L. SID (B)(6) (83-YEAR-OLD FEMALE): (B)(6) 2025 ALINITY I AFP INITIAL RESULT = 23.2 G/L, REPEAT RESULT = 1.5 G/L SID (B)(6) (64- YEAR-OLD MALE): (B)(6) 2025 ALINITY I AFP INITIAL RESULT = 20.1 G/L, REPEAT RESULT = 12.6 G/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757037 ↗
• MalfunctionOct 29, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I AFP FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE <=8.8 UG/L): ON (B)(6) 2025, SID (B)(6), INITIAL AFP RESULT (B)(6) = 559.12 UG/L; (B)(6) 2025, ANOTHER SAMPLE WAS COLLECTED, SID (B)(6), INITIAL RESULT (B)(6) = 6.37 UG/L; (B)(6) 2025, REPEAT RESULT= 5.78 UG/L, (B)(6) 2025, REPEAT RESULT ON ANOTHER ANALYZER (B)(6 )= 5.69 UG/L. ADDITIONAL RESULTS PROVIDED: CA125 RESULT= 3.6 U/ML; CEA RESULT= 1.00 UG/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23421164 ↗
• MalfunctionAug 4, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I AFP RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS </=8.8 UG/L): SAMPLE ID (B)(6), INITIAL RESULT, ON (B)(6) 2025, WAS 62.65, REPEAT RESULT WAS 4.26, REPEAT RESULT, ON ANOTHER ANALYZER, WAS 3.90 UG/L. ADDITIONAL LABORATORY RESULTS WERE PROVIDED: CEA WAS 3.8 UG/L, TPSA WAS <0.025 UG/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22708768 ↗
• MalfunctionApr 10, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSE ELEVATED ALINITY I AFP AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SAMPLE (B)(6) INITIAL RESULT WAS 83.7 UG/LAND REPEAT RESULT ON ANOTHER ANALYZER WAS <2 UG/L. NO FURTHER PATIENT DATA WAS PROVIDED. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21819378 ↗
• MalfunctionMay 31, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I AFP RESULTS FOR ONE PATIENT SAMPLE. THE CUSTOMER WAS UNABLE TO PROVIDE THE PATIENT¿S MEDICAL HISTORY AND INFORMATION. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2023 SID (B)(6). INITIAL RESULT = 20.15 NG/ML RESULT ON DIFFERENT MODULE (METHOD UNKNOWN) = 2.1 REPEAT RESULT ON THE SAME ANALYZER = 2.63 NG/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17035169 ↗