Aptima® APTIMA VAGINAL SWAB COLLECTION KITRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 25420045506258), received between Sep 14, 2017 and Nov 17, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2017Adverse Event Without Identified Device or Use Problem

  (B)(6) (CUSTOMER) REPORTED THAT (B)(6) (NURSE) AT THEIR SITE INADVERTENTLY SPLASHED SOME TRANSFER SOLUTION INTO AN EYE WHILE BREAKING A VAGINAL SWAB IN THE TUBE. THE SWAB WITH THE SPECIMEN WAS ALREADY IN SOLUTION. THE NURSE IMMEDIATELY FLUSHED THE AFFECTED EYE WITH WATER PER THE INSTRUCTIONS PROVIDED IN THE SAFETY DATA SHEET. IN ADDITION, (B)(6) FLUSHED (B)(6) EYE USING A 10 CC SYRINGE WITH STERILE WATER. PER OSHA GUIDELINES, A 'GENERAL ACCIDENTAL CHEMICAL EXPOSURE INCIDENT REPORT' FORM WAS FILLED OUT. NO PROFESSIONAL MEDICAL TREATMENT WAS SOUGHT AS THE AFFECTED INDIVIDUAL HAD NOT COMPLAINED ABOUT ANY FURTHER MEDICAL ISSUES REGARDING THIS INCIDENT.

  Patient problems: Chemical Exposure; Eye Injury

  MAUDE report 7041805 ↗
• InjurySep 14, 2017Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER, (B)(6) AT (B)(6), CALLED TO REPORT ONE OF THEIR COLLECTION SITES, (B)(6) HOSPITAL LAB, HAD BEEN USING VAGINAL SWAB COLLECTION KITS TO COLLECT ENDOCERVICAL SPECIMENS. THE SITE HAD DEPLETED THEIR STOCK OF UNISEX SWAB COLLECTION KITS. HOLOGIC TECHNICAL SUPPORT ADVISED THE CUSTOMER THAT THIS IS OFF LABEL AND THAT ONLY THE UNISEX SWAB COLLECTION KIT SHOULD BE USED TO COLLECT ENDOCERVICAL SWAB SPECIMENS. THE SITE RAN OFF PI FOR ABOUT ONE WEEK. THE CUSTOMER TESTED THESE SWAB SPECIMENS WITH THE APTIMA COMBO 2 AND APTIMA TRICHOMONAS VAGINALIS ASSAYS. HOLOGIC EVALUATED THIS ISSUE AND DETERMINED THE RISK TO BE SERIOUS AS AN INCORRECT OR INVALID RESULT DUE TO IMPROPER OR INADEQUATE SAMPLE COLLECTION MAY RESULT IN A DELAY OR FAILURE TO IDENTIFY A CONDITION THAT REQUIRES MEDICAL INTERVENTION. THE CUSTOMER MAY REPORT INCORRECT PATIENT RESULTS AS THE RESULT OF TESTING AN IMPROPER SAMPLE TYPE. ENDOCERVICAL SWAB SPECIMENS COLLECTED USING THE APTIMA VAGINAL SWAB SPECIMEN COLLECTION HAVE NOT BEEN EVALUATED FOR USE WITH THE APTIMA COMBO 2 OR APTIMA TRICHOMONAS VAGINALIS ASSAYS. HOLOGIC TS ADVISED THE CUSTOMER TO USE THE CORRECT TYPE OF SWAB ONLY PER PI.

  Patient problems: Unspecified Infection

  MAUDE report 6867476 ↗