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Alinity 08P1930Recalls & reported problems

Abbott GmbH · Alinity c Magnesium Reagent Kit 3600 Tests · 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 00380740121846), received between Mar 18, 2021 and Mar 18, 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.

  • MalfunctionMar 18, 2021High Test Results; High Test Results

    THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR ONE PATIENT. ON (B)(6) 2021, PATIENT SID (B)(6) GENERATED AN INITIAL MAGNESIUM RESULT OF 3.33 MMOL/L (THE RESULT WAS NOT REPORTED), REPEATED THE SAMPLE WITH A RESULT OF 0.90 MMOL/L. THE SAMPLE WAS RE-RAN BY 10 AND RESULTS WERE BETWEEN 0.90 MMOL/L AND 0.93 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11515612 ↗

Other PHOTOMETRIC METHOD, MAGNESIUM devices

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