Alinity m 09N17-095Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884999048591), received between Feb 19, 2025 and Feb 19, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Negative Result” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Sep 12, 2024Class IIOpen, Classified

   Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.

   Z-0234-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionFeb 19, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A DISCREPANT RESULT FOR THE CT (CHLAMYDIA TRACHOMATIS) TARGET ON THE ALINITY M STI ASSAY. SID (SAMPLE ID) (B)(6) WAS TESTED 3 TIMES ON (B)(6) 2025. 1.) ON (B)(6)2025, COMPLETED AT 10:09AM, FCN: 28.27, NORMAL AMPLIFICATION, "POSITIVE". APU3,9 2.) ON (B)(6)2025, COMPLETED AT 1:03PM, FCN: -1 "NEGATIVE" BUT APPEARED TO AMPLIFY ON MQANALYZE. 3.) ON (B)(6)2025, COMPLETED AT 3:27PM, FCN: -1, "NEGATIVE" BUT LOOKED LIKE IT AMPLIFIED ON MQANALYZE. SAMPLE WAS URINE AND WAS RAN ONE AFTER THE OTHER ON THE SAME ALINITY M TO DOUBLE/TRIPLE CHECK THE CT RESULT. THE TAS (TECHNICAL APPLICATION SPECIALIST) CHECKED THE RESULT LOGS AND RAN CURVES IN MQANALYZE TO VERIFY CUSTOMER CLAIMS. ALL ABOVE WERE TRUE AND CURVES LOOKED NORMAL AND SMOOTH ON THE FAM FILTER TYPE FOR CT. THE CURVES AMPLIFIED FOR THE 2ND AND 3RD ATTEMPTS BUT THE RESULT WAS A "NEGATIVE." CLINICIAN REPORTED RESULT TO PATIENT AS "EQUIVOCAL" AND REQUESTED A RETRY. THE CUSTOMER DOES NOT DEEM THE RESULT AS A "FALSE POSITIVE OR FALSE NEGATIVE" BUT AS DISCREPANT. THERE HAS BEEN NO REPORT OF IMPACT TO PATIENT MANAGEMENT. IN THE ABSENCE OF ADDITIONAL INFORMATION, THIS REPORT IS BEING FILED AS A POTENTIAL FALSE NEGATIVE RESULT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21413974 ↗