Alinity m 09N43-095Recalls & reported problems
Abbott Molecular Inc. · Alinity m EBV AMP Kit · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884999049505), received between Feb 27, 2023 and Jan 20, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (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.
Reports received per month
Most reported problems
Device problems
- False Negative Result1
- False Positive Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 20, 2026False Negative Result
THE CUSTOMER REPORTED FALSE NOT DETECTED RESULTS ON THE ALINITY M EBV AMP KIT. THE CUSTOMER REPORTED 1 PATIENT HAD 2 FALSE NOT DETECTED RESULTS: SAMPLE ID (SID) (B)(6) WAS "NOT DETECTED" FOR EBV-PLASMA PROTOCOL ON (B)(6) 2025. IN ADDITION SID (B)(6) (VIRAL LOAD OF 1479 IU/ML FOR WHOLE BLOOD) WAS "NOT DETECTED" FOR EBV-PLASMA ON (B)(6) 2025 AS WELL. THE PATIENT HAS A CHRONIC T-CELL EBV INFECTION AND HAS BEEN POSITIVE WITH COMPARABLE VALUES SINCE (B)(6) 2025 (CONFIRMED THROUGH REFERENCE LAB IN PARIS). THE CUSTOMER IS ALLEGING THAT ALL NOT DETECTED RESULTS FOR THAT PATIENT ARE QUESTIONED AS THE PATIENT HAS A KNOWN EBV INFECTION CONSTANTLY SHOWING SINCE (B)(6) 2025 (ALSO IN SEROLOGY). BASED ON THIS INFORMATION PROVIDED, THE CUSTOMER IS ALLEGING DISCREPANT FALSE NOT DETECTED RESULTS ON EBV-PLASMA (LIST NUMBER 09N43-91) FOR SID (B)(6) AND SID (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24121824 ↗MalfunctionFeb 27, 2023False Positive Result; False Positive Result
THE CUSTOMER REPORTED DISCREPANT (FALSE DETECTED) ALINITY EBV RESULTS WITH LOWER LIMIT OF QUANTIFICATION (LLOQ). SAMPLE ID, ALINITY RESULT, DATE, MAYO RESULT : (B)(6). MAYO RESULTS WERE GENERATED USING AN ALTERNATIVE PLATFORM (ROCHE MOLECULAR). THERE WAS NO IMPACT TO PATIENT MANAGEMENT FOR THE SAMPLE IDS LISTED ABOVE. MAYO RESULTS WERE RELEASED TO PROVIDER. THE REPORTED EVENT WAS CONSIDERED FALSE DETECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16450192 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.