Alinity 07P6230Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380740130862), received between Aug 16, 2023 and Jun 17, 2024 — 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.

• MalfunctionJun 17, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I CEA RESULT ON ONE 63 YEAR OLD MALE PATIENT DIAGNOSED WITH ASTHMA/COPD/PULMONARY FIBROSIS/HISTORY OF SMOKING. THE PATIENT HAS NOT BEEN DIAGNOSED WITH CANCER. THE FOLLOWING DATA WAS PROVIDED: ALINITY RESULT PROCESSED ON (B)(6) 2024 = 46.31 NG/ML HISTORICAL RESULTS: (B)(6) 2024 = 40.9 NG/ML (B)(6) 2024 = 31.4 NG/ML (B)(6) 2021 = 16.8 NG/ML THE CUSTOMER REPORTED THAT A CHEST/ABDOMINAL CT SCAN(WITHOUT CONTRAST) AND A UPPER/LOWER DIGESTIVE ENDOSCOPY WAS PERFORMED DUE TO THE FALSELY ELEVATED ALINITY I CEA RESULT OF 40.9 NG/ML, BUT NO MALIGNANT TUMOR WAS FOUND. THE CUSTOMER STATED THERE WAS NO HARM TO THE PATIENT. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547939 ↗
• MalfunctionAug 16, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED ALINITY I CEA RESULT FOR A CANCER PATIENT. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID 406218372 INITIAL RESULT, ON (B)(6) 2023, WAS <2 UG/L. THE PATIENT WAS REDRAWN AND TESTED ON (B)(6) 2023, AND THE RESULT WAS 381 UG/L. THE PATIENT WAS REDRAWN AND TESTED ON (B)(6) 2023, AND THE RESULT WAS 321 UG/L. THE PATIENT¿S PREVIOUS RESULT, ON (B)(6) 2023, WAS 193 UG/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560295 ↗