Aptima® MULTITEST SWAB COLLECTION KIT,APTIMA,IVDRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 25420045510187), received between Aug 11, 2021 and Aug 16, 2026 — classified as 16 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (15 reports).

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryAug 16, 2026Material Separation

  On (b)(6) 2026, a customer in Canada reported to Hologic that the cotton portion of the swab tip from an Aptima Multitest Specimen Collection Kit unraveled and almost detached from the stick during rectal specimen collection on (b)(6) 2026. Customer did not provide the lot of the Aptima Multitest Swab Specimen Collection Kit. Hologic has not learned of any adverse outcomes related to this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50267492 ↗
• MalfunctionAug 10, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50194697 ↗
• InjuryJul 22, 2026Material Separation

  ON (B)(6), 2026, A CUSTOMER FROM NETHERLANDS REPORTED TO HOLOGIC THAT ON (B)(6),2026, THE TIP OF A SWAB, INCLUDED IN THE APTIMA MULTITEST SPECIMEN COLLECTION KIT (LOT NUMBER: 931499) DETACHED FROM THE SWAB SHAFT DURING SPECIMEN COLLECTION. NO FURTHER INFORMATION WAS PROVIDED TO HOLOGIC. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25906294 ↗
• InjuryJul 16, 2026Material Separation

  ON (B)(6) 2026, A CUSTOMER FROM NETHERLANDS REPORTED TO HOLOGIC THAT ON (B)(6) 2026, THE TIP OF A SWAB, INCLUDED IN THE APTIMA MULTITEST SPECIMEN COLLECTION KIT (LOT NUMBER: 932841) DETACHED FROM THE SWAB SHAFT DURING RECTAL SPECIMEN COLLECTION AND REMAINED INSIDE THE PATIENT. THE CUSTOMER STATED THAT THE PATIENT REMOVED THE SWAB TIP THEMSELVES. NO FURTHER INFORMATION ON THE PATIENT¿S STATUS WAS PROVIDED TO HOLOGIC. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25845770 ↗
• InjuryJul 1, 2026Material Separation

  ON (B)(6) 2026, A CUSTOMER FROM NETHERLANDS REPORTED TO HOLOGIC THAT THE TIP OF MULTIPLE SWABS, INCLUDED IN THE APTIMA MULTITEST SPECIMEN COLLECTION KIT (LOT NUMBER: 932841) DETACHED FROM THE SWABS SHAFT AND REMAINED INSIDE THE PATIENTS DURING RECTAL SPECIMEN COLLECTION. THE CUSTOMER STATED THAT THE PATIENTS REMOVED THE SWAB TIP THEMSELVES. NO FURTHER INFORMATION ON THE PATIENT¿S STATUS WAS PROVIDED TO HOLOGIC. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25678312 ↗
• InjuryJun 23, 2026Material Separation

  ON (B)(6) 2026, A CANADIAN CUSTOMER REPORTED TO HOLOGIC THAT DURING RECTAL SPECIMEN COLLECTION WITH THE APTIMA MULTITEST SPECIMEN COLLECTION KIT (LN 933932), A PORTION OF THE SWAB TIP FIBERS REMAINED INSIDE THE PATIENT AND HAD TO BE PHYSICALLY REMOVED. NO FURTHER INFORMATION ON THE PATIENT¿S STATUS AFTER LEAVING THE CLINIC WAS PROVIDED TO HOLOGIC. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25595231 ↗
• MalfunctionJun 15, 2026Material Separation

  ON (B)(6) 2026, A CUSTOMER REPORTED TO HOLOGIC THAT THEY HAD AN APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT THAT CONTAINED SWABS MISSING THE TIP OR WITH DEFECTIVE SWABS. CUSTOMER DID NOT PROVIDE THE LOT OF THE APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT. NO INJURIES WERE REPORTED AS A RESULT OF THIS EVENT. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25503550 ↗
• InjuryJun 15, 2026Material Separation

  ON (B)(6) 2026, A CUSTOMER REPORTED TO HOLOGIC THAT THE TIP OF MULTIPLE SWABS, INCLUDED IN THE APTIMA MULTITEST SPECIMEN COLLECTION KIT (LNS 931935 AND 925009) DETACHED FROM THE SWABS SHAFT AND REMAINED INSIDE THE PATIENTS DURING SPECIMEN COLLECTION. THE CUSTOMER CONFIRMED THAT MEDICAL ASSISTANCE WAS REQUIRED TO REMOVE THE SWAB TIPS FROM THE PATIENTS. NO FURTHER INFORMATION ON THE PATIENTS¿ STATUS WAS PROVIDED TO HOLOGIC. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25502992 ↗
• InjuryMay 19, 2026Material Separation

  ON (B)(6) 2026, A CUSTOMER REPORTED TO HOLOGIC THAT THE TIP OF MULTIPLE SWABS, INCLUDED IN THE APTIMA MULTITEST SPECIMEN COLLECTION KIT (LN 931935) DETACHED FROM THE SWABS SHAFT AND REMAINED INSIDE THE PATIENTS DURING VAGINAL SPECIMEN COLLECTION. THE CUSTOMER DID NOT SPECIFY HOW THE SWAB SHAFTS WERE REMOVED FROM THE PATIENTS. NO FURTHER INFORMATION ON THE PATIENTS¿ STATUS WAS PROVIDED TO HOLOGIC. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25219684 ↗
• InjuryMay 11, 2026Material Separation

  ON (B)(6) 2026, A CUSTOMER REPORTED TO HOLOGIC THAT THE TIP OF MULTIPLE SWABS, INCLUDED IN THE APTIMA MULTITEST SPECIMEN COLLECTION KIT (LN 931935) DETACHED FROM THE SWABS SHAFT AND REMAINED INSIDE THE PATIENTS DURING VAGINAL SPECIMEN COLLECTION. THE DETACHED SWAB TIPS WERE SUBSEQUENTLY REMOVED FROM THE PATIENTS VIA MEDICAL PROCEDURE. NO FURTHER INFORMATION ON THE PATIENTS¿ STATUS WAS PROVIDED TO HOLOGIC. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137455 ↗
• InjuryApr 10, 2026Material Separation

  ON (B)(6) 2026, A CANADIAN CUSTOMER REPORTED TO HOLOGIC THAT ON (B)(6) 2026, THE TIP OF FOUR SWABS, INCLUDED IN THE APTIMA MULTITEST SPECIMEN COLLECTION KIT (LN 926573) DETACHED FROM THE SWABS SHAFT AND REMAINED INSIDE THE PATIENTS DURING RECTAL SPECIMEN COLLECTION. THE CLINICIAN WAS ABLE TO REMOVE THE SWAB TIP FROM THE PATIENTS. FOR ONE OF THE PATIENTS, THE ISSUE OCCURRED WITH 2 SWABS, AND THE SPECIMEN WAS COLLECTED SUCCESSFULLY ON THE THIRD ATTEMPT. NO FURTHER INFORMATION ON THE PATIENTS¿ STATUS WAS PROVIDED TO HOLOGIC. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845479 ↗
• InjuryFeb 18, 2026Material Separation

  ON (B)(6) 2026, A CANADIAN CUSTOMER REPORTED TO HOLOGIC THAT THE TIP OF THE SWAB, INCLUDED IN THE APTIMA MULTITEST SPECIMEN COLLECTION KIT (LN 926573) DETACHED FROM THE SWAB SHAFT AND REMAINED INSIDE THE PATIENT DURING RECTAL SPECIMEN SELF-COLLECTION IN THE CLINIC. THE PATIENT INFORMED THE CLINICIAN BUT REFUSED CLINICIAN ASSISTANCE AND CHOSE TO ATTEMPT REMOVAL OF THE SWAB TIP AT HOME. THE PATIENT WAS MADE AWARE THAT IF THE SWAB COULD NOT BE REMOVED, THEY COULD RETURN TO THE CLINIC FOR ASSISTANCE. NO FURTHER INFORMATION ON THE PATIENT¿S STATUS AFTER LEAVING THE CLINIC WAS PROVIDED TO HOLOGIC. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379457 ↗
• InjuryOct 28, 2025Material Separation; Material Separation

  ON (B)(6) 2025, CUSTOMER REPORTED TO HOLOGIC THAT IN TWO SEPARATE PATIENT ENCOUNTERS, THE SWAB TIP FROM THE APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT (LN 922935) DETACHED FROM THE STICK AND REMAINED INSIDE THE PATIENT. CUSTOMER REPORTED THAT THE TWO PATIENT ENCOUNTERS OCCURRED WITHIN 24 HOURS PRIOR TO THEIR REPORT TO HOLOGIC. IN BOTH INSTANCES, THE PHYSICIAN WAS ABLE TO REMOVE THE SWAB TIP WITHOUT ANY REPORTED PATIENT HARM. CUSTOMER DID NOT PROVIDE PATIENT INFORMATION OR CONFIRMATION OF SWAB SPECIMEN TYPE OR COLLECTION METHOD. THIS REPORT IS TO DOCUMENT THE SECOND AFFECTED PATIENT ENCOUNTER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407950 ↗
• InjuryOct 28, 2025Material Separation; Material Separation

  ON (B)(6) 2025, CUSTOMER REPORTED TO HOLOGIC THAT IN TWO SEPARATE PATIENT ENCOUNTERS, THE SWAB TIP FROM THE APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT (LN 922935) DETACHED FROM THE STICK AND REMAINED INSIDE THE PATIENT. CUSTOMER REPORTED THAT THE TWO PATIENT ENCOUNTERS OCCURRED WITHIN 24 HOURS PRIOR TO THEIR REPORT TO HOLOGIC. IN BOTH INSTANCES, THE PHYSICIAN WAS ABLE TO REMOVE THE SWAB TIP WITHOUT ANY REPORTED PATIENT HARM. CUSTOMER DID NOT PROVIDE PATIENT INFORMATION OR CONFIRMATION OF SWAB SPECIMEN TYPE OR COLLECTION METHOD. THIS REPORT IS TO DOCUMENT THE FIRST AFFECTED PATIENT ENCOUNTER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407944 ↗
• MalfunctionOct 27, 2025Material Separation; Material Separation

  ON (B)(6) 2025, CUSTOMER REPORTED TO HOLOGIC THAT THEY HAD AN APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT (LN 922935) BOX THAT CONTAINED SWABS WITH TIPS THAT WERE DETACHING FROM THE STICK. CUSTOMER REPORTED THEY WERE UNABLE TO USE THE SWABS IN THE KIT BOX. NO INJURIES WERE REPORTED AS A RESULT OF THIS EVENT, AND NO PATIENTS WERE AFFECTED AS THE SWABS WERE UNUSED. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393155 ↗
• InjuryAug 31, 2023Break; Break

  ON (B)(6) 2023, A HOLOGIC MOLECULAR APPLICATIONS SPECIALIST (MAS) REPORTED ON BEHALF OF A CUSTOMER THAT THE SWAB SOFT TIP OF THE APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT DETACHED FROM THE SWAB SHAFT AND GOT STUCK INSIDE THE VAGINAL CAVITY OF A FEMALE PATIENT DURING SELF-COLLECTION. THE PATIENT WAS USING A SWAB FROM THE APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT, LOT NUMBER 331515V. AFTER THIS INCIDENT, A PHYSICIAN REMOVED THE SWAB SOFT TIP FROM THE PATIENT. THEN, THE PATIENT RECEIVED ANOTHER APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT FOR SELF-COLLECTION OF A VAGINAL SPECIMEN, BUT THE SWAB SOFT TIP DETACHED AGAIN AND WAS LEFT IN THE PATIENT¿S VAGINAL CAVITY. THE PATIENT ONCE AGAIN HAD TO CONSULT A PHYSICIAN TO HAVE THE SWAB SOFT TIP REMOVED. PER CUSTOMER FEEDBACK, THE CUSTOMER IS UNSURE IF THE PATIENT WAS ADEQUATELY INFORMED OF THE DEVICE'S INSTRUCTIONS FOR USE PRIOR TO THE PATIENT USING APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT. THE CUSTOMER INDICATED THAT THE PATIENT DID NOT NOTICE ANY DAMAGE TO DEVICE PRIOR TO USAGE. NO INJURIES WERE REPORTED TO HOLOGIC FROM THIS INCIDENT. HOLOGIC IS REPORTING THIS INCIDENT BECAUSE A MEDICAL INTERVENTION WAS REQUIRED TO PREVENT TEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17666144 ↗
• InjuryApr 22, 2022Off-Label Use; Off-Label Use

  ON (B)(6) 2022, CUSTOMER REPORTED TO HOLOGIC TECHNICAL SUPPORT (TS) THAT A PATIENT'S CHILD INGESTED SPECIMEN TRANSPORT MEDIA (STM) FROM AN APTIMA MULTITEST TRANSPORT TUBE. TS DIRECTED THE CUSTOMER TO SAFETY DATA SHEET (SDS) OF THE PRODUCT FOR FIRST AID GUIDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14182727 ↗
• InjurySep 24, 2021No Apparent Adverse Event; No Apparent Adverse Event

  INITIAL/FINAL: ON 09/07/21, HOLOGIC WAS MADE AWARE OF A MEDICAL DEVICE REPORT (MDR) # 0800220000-2021- 8055 FILED WITH THE CDRH/FDA DIVISION OF MICROBIOLOGY DEVICES. THE REPORT PURPORTS THAT APTIMA MULTITEST SWAB COLLECTION KITS (PART NUMBER [PN]: ASY-08848) FROM LOT NUMBER (LN) 289723 CONTAINED EMPTY SPECIMEN COLLECTION TUBES DUE TO LOOSE CAPS. IT LATER RELAYED TO HOLOGIC THAT THE REPORTING LAB REJECTED SOME LAB SAMPLES THAT ARRIVED WITHOUT THE EXPECTED LIQUID IN THE SWAB MEDIUM TUBES. HOLOGIC REVIEWED THE MANUFACTURING RECORD OF THE AFFECTED LOT AND DID NOT FIND ANY NONCONFORMANCE RELATED TO THE ISSUE. HOLOGIC ALSO INSPECTED THE RETENTION OF THE AFFECTED KIT AND NO EMPTY TUBES OR SIGNS OF LEAKAGE WERE FOUND. FURTHER INVESTIGATION COULD NOT BE CONDUCTED BECAUSE NO FURTHER INFORMATION, PHOTOS AND THE ACTUAL BOTTLES WERE NOT RETURNED BY THE CUSTOMER. NO SIMILAR COMPLAINTS WERE FOUND FOR THE REPORTED LOT. THERE ARE CONTROL/MITIGATIONS IN PLACE TO PREVENT REPORTING FALSE RESULTS: THE INSTRUMENT WILL INVALIDATE ANY SAMPLE THAT DOES HAVE THE REQUIRED VOLUME. NO INCORRECT RESULTS WERE REPORTED TO HOLOGIC AS A RESULT OF THIS ISSUE. IT WAS RELAYED TO HOLOGIC THAT THE SAMPLES WERE REJECTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530382 ↗
• InjuryAug 11, 2021No Apparent Adverse Event; No Apparent Adverse Event

  FOLLOW-UP/FINAL. ON 06/11/2021, THE FDA RECEIVED A REPORT (MW5101852) THROUGH THE FDA'S MEDWATCH PROGRAM. THE REPORT WAS FORWARDED BY THE FDA TO HOLOGIC AND WAS RECEIVED ON 07/16/2021. A CUSTOMER SUBMITTED A MDR TO THE FDA REGARDING A BOX OF SPECIMEN COLLECTION KITS, MULTITEST SWAB, IVD (PN: PRD-03546) WHICH CONTAINS MULTITEST SWAB SPECIMEN COLLECTION KITS (PN: ASY-00848, LN: 288775). THE REPORT STATED THAT THERE WERE MULTIPLE INSTANCES WHERE THE SWAB BULB FROM APTIMA MULTITEST SWABS DETACHED DURING COLLECTION OF VAGINAL SAMPLES WHEN USING STANDARD SPECIMEN COLLECTION PROCEDURES. IN MULTIPLE INSTANCES THE PROVIDER NEEDED TO PERFORM A SPECULUM EXAM TO REMOVE THE RETAINED MATERIAL. THE REPORT DID NOT PROVIDE DATES FOR WHEN THESE INSTANCES OCCURRED, AND DID NOT INCLUDE PICTURES OF THE IMPACTED SWABS FOR ASSESSMENT. THE REPORT ALSO DID NOT INDICATE THAT THERE WAS AN INJURY AS A RESULT OF RETRIEVING THE BULBS FROM THE PATIENTS. THE PACKAGE INSERT "APTIMA® MULTITEST SWAB SPECIMEN COLLECTION KIT" AW-14413-001 REV. 010 STATES "GENTLY ROTATE THE SWAB FOR 10 TO 30 SECONDS" FOR VAGINAL SWAB COLLECTION. HOLOGIC REQUESTED THE SWAB SUPPLIER TO PERFORM FURTHER INVESTIGATION. SUPPLIER CHECKED THEI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12310921 ↗