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Alinity 08P4020Recalls & reported problems

Abbott GmbH · Alinity c Phosphorus Reagent Kit 4000 test · Class 1

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 00380740135126), received between Jul 22, 2019 and Jul 22, 2019 — 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 Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJul 22, 2019High Test Results; High Test Results

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY C PHOSPHORUS RESULT FOR 1 SAMPLE. THE FOLLOWING DATA WAS PROVIDED (UNITS OF MEASURE = MMOL/L, REFERENCE RANGE = 0.74-1.52 MMOL/L): INITIAL RESULT = 3.22, REPEAT = 1.23. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8813291 ↗

Other Phosphomolybdate (colorimetric), inorganic phosphorus devices

All Phosphomolybdate (colorimetric), inorganic phosphorus devices →

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