Alinity 08P0702Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740146252), received between Feb 23, 2021 and Feb 23, 2021 — 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.

• MalfunctionFeb 23, 2021High Test Results; High Test Results

  ABBOTT IDENTIFIED INTERNALLY A MANUFACTURING ISSUE WHERE INDIVIDUAL VIALS OF THE ALINITY I HAVAB IGG CALIBRATOR WERE MISLABELED AS HIV AG/AB COMBO CALIBRATOR. IMPACTED VIALS CAN CAUSE INVALID CALIBRATIONS DUE TO LOW RLU (RELATIVE LIGHT UNITS) CALIBRATOR SIGNALS. WHEN CALIBRATING USING AN IMPACTED VIAL, THE CUSTOMER WILL OBSERVE EITHER: ERROR CODE; 1400: CALIBRATION FAILED FOR ALINITY I HIV AG/AB COMBO ASSAYS (CV TOO LARGE FOR CAL 1) OR, IF A CALIBRATION PASSES, THE QUALITY CONTROL VALUES WILL BE OUT OF RANGE HIGH AND THE CALIBRATIONS ARE INVALID. THE EFFECT OF THESE LOW CALIBRATOR RLU VALUES WAS OBSERVED INTERNALLY AFTER LOT RELEASE TESTING WAS COMPLETED. THERE IS NO IMPACT TO PATIENT RESULTS, HOWEVER, INVALID CALIBRATIONS MAY CAUSE A DELAY IN RESULTS. NON-IMPACTED CALIBRATOR VIALS WILL PERFORM AS EXPECTED. THERE HAS BEEN NO REPORTED DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11365843 ↗