Alinity 04T9820Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740168285), received between Sep 12, 2023 and Sep 12, 2023 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED QC BEING OUT OF RANGE FOR ALINITY C IRON2. THE CUSTOMER FURTHER COMMUNICATED THAT THEY RANDOMLY RETESTED PATIENT SAMPLES OUT OF A TOTAL OF 70 ON ANOTHER ALINITY C PROCESSING MODULE AND NOTED FALSELY ELEVATED RESULTS. THE CUSTOMER WAS NOT ABLE TO PROVIDE PATIENTS¿ AGE AND PROVIDED THE FOLLOWING DATA: CUSTOMER NORMAL RANGE: 0-14 YEARS: 2.9 -22.9 MOL/L, FEMALE 14 - 19 YEARS: 3.6 - 29.0 MOL/L, MALE 14 - 19 YEARS: 5.5 - 30.1 MOL/L, ADULT FEMALE: 9.0 - 30.4 MOL/L, ADULT MALE: 11.6 - 31.3 MOL/L THE INITIAL RESULT WAS FROM SN: (B)(6) AND REPEAT RESULT WAS FROM SN: (B)(6) SAMPLE INITIAL RESULT WAS 64.2, REPEAT RESULT WAS 52.5. PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENTS¿ MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17730662 ↗