Aptima® KIT, BOX 1, REFRIGERATED, ABV, 100T, IVDRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15420045512023), received between Jul 22, 2022 and Jul 22, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Imprecise or Erratic 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionJul 22, 2022Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2022, A CUSTOMER REPORTED DISCREPANT RESULTS TO HOLOGIC FOR THE APTIMA BACTERIAL VAGINOSIS (BV) ASSAY FROM, PN ASY-11550 LOT NUMBER 318661. INITIAL RUN RESULTS INDICATE A NEGATIVE BV RESULT. RETEST RESULTS INDICATE A BV POSITIVE RESULT. PER CUSTOMER REQUEST, HOLOGIC REVIEWED THE LOGS AND NOTIFIED CUSTOMER OF POTENTIALLY AFFECTED SAMPLES. THE CUSTOMER RETESTED THE SAMPLES AND IDENTIFIED TWO SAMPLES THAT WERE DISCORDANT. THE CUSTOMER INDICATED THAT THEY CORRECTED THE REPORT FOR THESE SPECIMENS TO BV POSITIVE. THERE IS NO INDICATION THAT AN ADVERSE EVENT OCCURRED (THE PATIENT WAS IMPACTED) DUE TO THE INCORRECT RESULT. REVIEW OF CUSTOMER DATA BY HOLOGIC NOTED THAT PREVIOUS ABV RUNS HAD THE ¿CCE¿ FLAG, WHICH IS A CALIBRATION CHANNEL ERROR. PER AW-20220-001, REV. 001, THE PANTHER/PANTHER FUSION OPERATOR¿S MANUAL INDICATES TO CONTACT HOLOGIC TECHNICAL SUPPORT WHEN THEY RECEIVE THE ¿CCE¿ ERROR CODE. THE ISSUE WAS LIKELY CAUSED BY DEBRIS IN THE RTF. ROOT CAUSE INVESTIGATION IS IN PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089973 ↗