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Alinity 07P7430Recalls & reported problems

Abbott GmbH · Alinity c Lactate Dehydrogenase Reagent Kit 1960 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 00380740130251), received between Dec 8, 2020 and Dec 8, 2020 — 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.

  • MalfunctionDec 8, 2020High Test Results; High Test Results

    THE CUSTOMER REPORTED FALSELY ELEVATED LDH RESULTS GENERATED ON THE ALINITY C ANALYZER ON MULTIPLE PATIENTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10970156 ↗

Other NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE devices

All NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE devices →

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