Alinity 08P2030Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740135171), received between Jan 29, 2024 and Jan 29, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Software 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.

• MalfunctionJan 29, 2024Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED ALKALINE PHOSPHATASE IFCC (INTERNATIONAL FEDERATION OF CLINICAL CHEMISTRY) CONVERSION FACTOR NOT ENTERED IN ASSAY PARAMETER SETTING BY THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSR), AT THE TIME OF MULTIPLE ALINITY CI PROCESSING MODULES SETUP. THE CUSTOMER REQUESTED IFCC METHOD FOR ALKALINE PHOSPHATASE ON ALINITY CI PROCESSING MODULE SINCE (B)(6) 2022 DURING THE TIME OF ALINITY CI SETUP. THE ALKALINE PHOSPHATASE IFCC SHOULD HAVE CALIBRATION FACTOR 2290 AND NON-IFCC CALIBRATION FACTOR 2150. THE CUSTOMER NOTICED THE NON-IFCC CALIBRATION FACTOR 2150 WHEN DOING NEW ALKALINE PHOSPHATASE REAGENT CALIBRATION, AT THAT TIME FIND OUT ABOUT THIS ISSUE. THERE SHOULD BE CONVERSION FACTOR ON ASSAY PARAMETER SETTING WHEN SELECT UNIT OF MEASURE THEN NEED TO ENTER CONVERSION FACTOR 1.0651 FOR IFCC METHOD AND THAT WAS NOT ENTERED BY THE FSR AT THE TIME OF SETUP OF ALINITY CI PROCESSING MODULE. THERE WAS NO INFORMATION PROVIDED BY THE CUSTOMER FOR DISCREPANT ALKALINE PHOSPHATASE RESULTS. THERE WAS NO TREATMENT CHANGED DUE TO DISCREPANT ALKALINE PHOSPHATASE RESULTS REPORTED. NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18597883 ↗