Aptima® APTIMA SWAB SPECIMEN COLLECTION KITRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 25420045506272), received between Apr 3, 2018 and Feb 25, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Off-Label Use

  ON (B)(6) 2026, CUSTOMER REPORTED THAT A SAMPLE WAS COLLECTED ON (B)(6) 2026, WITH AN APTIMA UNISEX SWAB SPECIMEN COLLECTION KIT FOR ENDOCERVICAL AND MALE URETHRAL SWAB SPECIMENS THAT HAD EXPIRED ON JANUARY 31, 2026. CUSTOMER NOTED THE AFFECTED SAMPLE WAS SENT OUT FOR TESTING WITH THE APTIMA COMBO 2 ASSAY AND INDICATED OTHER SAMPLES MAY HAVE BEEN COLLECTED IN EXPIRED KITS AND SENT FOR TESTING AS WELL. CUSTOMER WAS UNSURE HOW MANY SAMPLES MAY BE AFFECTED. CUSTOMER DID NOT PROVIDE LOT INFORMATION AS THEY HAD DISCARDED AFFECTED TUBES. CUSTOMER DID NOT REPORT ANY ISSUES WITH SAMPLE RESULTS AND DID NOT PROVIDE FURTHER INFORMATION ON PATIENT INFORMATION/TREATMENT OR RESULTS REPORTING. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444520 ↗
• InjuryAug 9, 2024Break; Break

  ON 07/23/24, A CUSTOMER CONTACTED HOLOGIC TO REPORT A BROKEN SWAB TIP THAT OCCURRED DURING SPECIMEN COLLECTION ON 07/19/24 USING THE APTIMA UNISEX SWAB SPECIMEN COLLECTION KIT, LOT NUMBER 880984V. ACCORDING TO THE CUSTOMER, APPROXIMATELY 1 CM OF THE SWAB TIP BROKE INSIDE THE CERVIX. THE TIP OF THE SWAB WAS SAFELY REMOVED BY THE PHYSICIAN WITH TWEEZERS AND NO INJURIES WERE REPORTED. NO ADDITIONAL TREATMENT WAS NEEDED. HOLOGIC IS REPORTING THIS INCIDENT BECAUSE A MEDICAL INTERVENTION WAS REQUIRED TO PREVENT TEMPORARY OR PERMANENT IMPAIRMENT OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951866 ↗
• InjuryAug 22, 2018Device Handling Problem; Device Handling Problem

  CUSTOMER, (B)(6), REPORTED AN INCIDENT WHERE A CHILD INGESTED AN UNKNOWN VOLUME OF APTIMA TRANSPORT MEDIA, PRIOR TO COLLECTION OF SAMPLE. THE SWAB COLLECTION TUBE CONTAINS SOLN., TRANSPORT MEDIA (PN: 101768). THE CHILD WAS GIVEN PLENTY OF WATER TO DRINK AS TREATMENT. PER THE SAFETY DATA SHEET FOR TRANSPORT MEDIA/COLLECTION DEVICES (REV. DATE 06/25/2018), THE FIRST AID MEASURE FOR INGESTION IS TO "CLEAN MOUTH WITH WATER AND DRINK AFTERWARDS PLENTY OF WATER. IF SYMPTOMS PERSIST, CALL A PHYSICIAN". IN ADDITION, THE PRODUCT CONTAINS NO SUBSTANCES, WHICH AT THEIR GIVEN CONCENTRATION, ARE CONSIDERED TO BE HAZARDOUS TO HEALTH. CUSTOMER HAS NOT CALLED BACK FOR ANY OTHER ISSUES.

  Patient problems: Injury

  MAUDE report 7806222 ↗
• InjuryApr 3, 2018Improper or Incorrect Procedure or Method

  CUSTOMER, (B)(6), CALLED TO REPORT THAT ONE OF THEIR TECHNICIANS WAS USING THE APTIMA UNISEX COLLECTION KIT TO COLLECT A RECTAL PATIENT SAMPLE, WHICH IS NOT CONSISTENT WITH THE COLLECTION KIT PACKAGE INSERT. THE OPERATOR ((B)(6)) COLLECTED THE PATIENT SWAB AND PLACED THE SWAB INTO THE COLLECTION TUBE. PRIOR TO CLOSING THE COLLECTION TUBE, TRANSPORT MEDIA CONTAINING THE PATIENT SWAB SPLASHED INTO THE OPERATOR'S EYE. THE OPERATOR THEN WASHED HER EYE WITH WATER AND CLEANED THE SKIN WITH SOAP AND WATER. THE OPERATOR WAS WEARING GLASSES AT THE TIME OF SAMPLE COLLECTION, BUT WAS NOT WEARING SAFETY GLASSES. THE PATIENT SAMPLE WAS TESTED WITH THE APTIMA COMBO 2 (AC2) ASSAY, AND THE RESULTS WERE DUAL (B)(6) FOR (B)(6). THE OPERATOR WAS EXAMINED BY A DOCTOR AND WILL CONTINUE TO BE MONITORED, BUT NO MEDICATIONS OR ANTIBIOTICS HAVE BEEN PRESCRIBED. PER HOLOGIC'S RISK ASSESSMENT, AS A RESULT OF PATIENT SAMPLE EXPOSURE, THE OPERATOR MAY HAVE BEEN INFECTED. THE SAMPLE IS KNOWN TO BE (B)(6) FOR (B)(6), BUT THE PRESENCE OF OTHER POTENTIALLY INFECTIOUS ORGANISMS CANNOT BE KNOWN.

  Patient problems: Exposure to Body Fluids; Unspecified Infection

  MAUDE report 7393103 ↗