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Alinity 08P3121Recalls & reported problems

Abbott GmbH · Alinity i Intact PTH Reagent Kit 200 Tests · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740136215), received between Apr 29, 2021 and Apr 29, 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

Device problems

  • High Test Results1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionApr 29, 2021High Test Results; High Test Results

    THE CUSTOMER OBSERVED FALSELY INCREASED ALINITY I INTACT PTH RESULTS FOR SEVERAL PATIENTS. THERE WERE COMPLAINTS ABOUT PATIENT RESULTS BEING ELEVATED FROM SEVERAL PHYSICIANS. SO, THE CUSTOMER SENT SOME OF THEIR SAMPLES TO ANOTHER LABORATORY TO COMPARE THE RESULTS ON THE OTHER LAB¿S ALINITY ANALYZER. THE FOLLOWING DATA WAS PROVIDED: THE CUSTOMER¿S RESULT WAS 55.0, OTHER LAB¿S RESULT WAS 33.1 PG/ML THE CUSTOMER¿S RESULT WAS 144.3, OTHER LAB¿S RESULT WAS 107.0 PG/ML THE CUSTOMER¿S RESULT WAS 82.1, OTHER LAB¿S RESULT WAS 61.0 PG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11748421 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.