Alinity 07P6220Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380740130855), received between Oct 27, 2022 and Jun 3, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED DISCREPANT ALINITY I CEA RESULTS GENERATED FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1 (B)(6) 2023 RESULT WITH OLD LOT 49146FN00 = 2.0, (B)(6) 2023 RESULT WITH NEW LOT 50043FN00 = 3.1. ADDITIONALLY, THE CUSTOMER ALSO NOTED A SHIFT UP IN QUALITY CONTROLS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19455274 ↗
• MalfunctionJun 3, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED DISCREPANT ALINITY I CEA RESULTS GENERATED FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1: ON (B)(6) 2023: RESULT WITH OLD LOT 49146FN00 = 2.0, ON (B)(6) 2023 RESULT WITH NEW LOT 50043FN00 = 3.1. ADDITIONALLY, THE CUSTOMER ALSO NOTED A SHIFT UP IN QUALITY CONTROLS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454372 ↗
• MalfunctionNov 15, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DEPRESSED ALINITY I CEA RESULT FOR A PATIENT SAMPLE. IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH CANCER. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6): TESTED WITH ANALYZER AI21440 = < 1.73 NG/ML. SAMPLE ID (B)(6): RETESTED TESTED WITH ANALYZER AI24617 = 9.86 NG/ML. SAMPLE ID (B)(6): RETESTED WITH ANALYZER AI21440 = 9.62 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145515 ↗
• MalfunctionOct 27, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED DISCREPANT ALINITY I CEA RESULTS FOR A 77-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: JULY RESULT (LOT 36540FN00) = 120.4 NG/ML, AUGUST RESULT (LOT 36543FN00) = 25.58 NG/ML, SEPTEMBER RESULT (LOT 39407FN00) = 79.6 NG/ML, OCTOBER RESULT (LOT 39407FN00) = 22.9 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15687189 ↗
• MalfunctionOct 27, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED DISCREPANT ALINITY I CEA RESULTS FOR A 77-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: JULY RESULT (LOT 36540FN00) = 120.4 NG/ML, AUGUST RESULT (LOT 36543FN00) = 25.58 NG/ML, SEPTEMBER RESULT (LOT 39407FN00) = 79.6 NG/ML, OCTOBER RESULT (LOT 39407FN00) = 22.9 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15687188 ↗