Alinity 08P4220Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380740132590), received between Jul 27, 2020 and Feb 25, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Low 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED ALINITY C CREATINE KINASE RESULT FOR ONE 13-YEAR-OLD PATIENT. THE LOW RESULT WAS NOT REPORTED. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 29-200 U/L): SID (B)(6) PROCESSED ON (B)(6) 2026 INITIAL RESULT WAS 576 WITH DILUTION. REPEAT RESULT = 5993 U/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443042 ↗
• MalfunctionJul 27, 2020Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED CREATINE KINASE (CK) RESULT GENERATED ON THE ALINITY C ANALYZER ON ONE PATIENT. RESULTS PROVIDED: ON (B)(6) 2020 SID (B)(6) = 95.6 U/L, REPEATED AT 95 U/L, ANOTHER LABORATORY = > 1000. IT WAS NOTED THAT THE SAMPLE WAS LIPEMIC AND THE CK RESULT WAS OBTAINED POST CENTRIFUGATION FOR 5 MINUTES / 10,000 RPM. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10326205 ↗