Alinity 09P6324Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740169916), received between Apr 9, 2024 and Apr 9, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Installation-Related Problem” (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.

• MalfunctionApr 9, 2024Installation-Related Problem; Installation-Related Problem

  THE CUSTOMER REPORTED A FALSELY DECREASED IMMUNOGLOBULIN M ON THE ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) INITIAL RUN (STANDARD 1:5 DILUTION) = >16.9 G/L, AUTOMATIC RERUN OF UNDILUTED SAMPLE = 1.045 G/L; RERUN WITH 1:20 MANUAL DILUTION = 40.724 G/L CONFIGURATION OF THE ASSAY IN THE ALINITY C SOFTWARE WAS PERFORMED IN AUGUST 2023. IF THE ANALYZER IS CONFIGURED AS G/L THE RANGE WOULD BE 0-0.25 AND IF CONFIGURED AS MG/DL THE RANGE WOULD BE 0-25. THE UNITS OF MEASURE WERE ENTERED AS G/L, BUT THE RANGE WAS NOT UPDATED TO 0-0.25 G/L. THE ANALYZER CONFIGURATION OF THE RERUN RULE WAS TO PERFORM AN AUTOMATIC RERUN OF AN UNDILUTED SAMPLE IF THE VALUE FELL WITHIN THE RANGE CONFIGURED IN THE SOFTWARE. SINCE THE ALINITY SOFTWARE WAS CONFIGURED WITH A RANGE OF 0-25 G/L, THE AUTOMATIC RERUN PROTOCOL WAS INCORRECT, AND THE SAMPLE WAS REPEATED AS AN UNDILUTED SAMPLE. THE SAMPLE NEEDED TO BE DILUTED PRIOR TO RERUNNING. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19070813 ↗