RealTime 8L07-91Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884999031142), received between Jan 18, 2019 and Jan 18, 2019 — classified as 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

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.

• MalfunctionJan 18, 2019False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT ONE SAMPLE ON THE ABBOTT CT/NG II ASSAY RUN HAD A "LOW-GRADE" POSITIVE RESULT. THE POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RE-TESTED, AND THE RESULT WAS NEGATIVE. THE MOLECULAR APPLICATION SPECIALIST (MAS) REVIEWED THE RUNS FROM ABBOTTLINK. THE SAMPLE IN QUESTION HAS GOOD IC (INTERNAL CONTROL) AMPLIFICATION IN BOTH RUNS. THE AMPLIFICATION CURVES AND REFERENCE DYE IN THE RUN LOOKED AS EXPECTED. THE SAMPLE WAS A SWAB. IN REGARDS TO THE QUESTIONED RESULTS REPORTED BY THE CUSTOMER, THE MAS EXPLAINED TO THE CUSTOMER THAT DUE TO NATURE OF THE SPECIMEN AND BEHAVIOR OF THE BACTERIAL DNA, THE REPEAT TEST MAY NOT HAVE PICKED UP ENOUGH BACTERIA TO HAVE THE CT DETECTED. THE CUSTOMER WILL REPORT THE SAMPLE AS "INCONCLUSIVE", AND THEY WILL REQUEST A REPEAT SPECIMEN. THERE WAS NO IMPACT ON THE PATIENT'S HEALTH DUE TO THE QUESTIONED RESULTS. BASED ON THE MAS REVIEW, THIS REPORT IS BEING PROCESSED AS A FALSE NEGATIVE ON THE REALTIME CT/NG II ASSAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8262246 ↗