AptimaRecalls & reported problems across all models
Hologic, Inc. · 15 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Aptima model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 82
- Deaths reported
- 0
- Injuries reported
- 71
- Recalls
- 2
We found 15 models of Aptima by Hologic, Inc. in the FDA's device registry (GUDID). Together they are named in 82 adverse event reports in the FDA's MAUDE database, received between Sep 14, 2017 and Sep 5, 2026 — classified as 71 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Imprecise or Erratic Results” (37 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Aptima recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 18, 2026Class IIOpen, Classified
Due to product exhibiting potential to generate either invalid or false negative results.
Z-1586-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- Sep 14, 2023Class IIOpen, Classified
Use of assay along with plasma specimen may result in error code which would invalidate sample.
Z-1371-2024 · Root cause: Use error · Recall details · FDA record ↗
Most reported Aptima problems
Device problems
- Imprecise or Erratic Results37
- Material Separation15
- False Positive Result5
- Off-Label Use4
- False Negative Result3
- No Apparent Adverse Event3
- Break2
- Difficult to Open or Close2
Patient problems
- No Clinical Signs, Symptoms or Conditions70
- Insufficient Information6
- Test Result2
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Chemical Exposure1
- Exposure to Body Fluids1
- Eye Injury1
Aptima models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Aptima® KIT, HPV, APTIMA, 250 TEST, REFRIG, IVDKit, rna detection, human papillomavirus1 recall32 reports
- Aptima® KIT, MAIN ASSAY, CMV, 100-TEST, IVDCytomegalovirus (cmv) dna quantitative assay1 recall2 reports
- Aptima® KIT,HPV,APTIMA,250 TEST,ROOM TEMP, IVDKit, rna detection, human papillomavirus1 recall0 reports
- Aptima® MULTITEST SWAB COLLECTION KIT,APTIMA,IVDHerpes simplex virus nucleic acid amplification assay19 reports
- APTIMA® KIT, MAIN ASSAY, HIV QUANT, 100T, US IVDTest, hiv detection9 reports
- Aptima® KIT, BOX 1, REFRIGERATED, ACV/TV, 100T, IVDVaginitis and bacterial vaginosis nucleic acid detection system4 reports
- APTIMA AC2, ROOM TEMP, 250T, READY MADENucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections4 reports
- Aptima® APTIMA SWAB SPECIMEN COLLECTION KITInstrumentation for clinical multiplex test systems4 reports
- Aptima® APTIMA VAGINAL SWAB COLLECTION KITDNA-REAGENTS, NEISSERIA2 reports
- Aptima® KIT, APTIMA HPV 16 18/45, 100 REF IVDKit, rna detection, human papillomavirus1 report
- Aptima® KIT, ATV-V2, REFRIGERATED, 100TTrichomonas vaginalis nucleic acid amplification test system1 report
- Aptima® KIT, BOX 1, REFRIGERATED, ABV, 100T, IVDAssayed external control material for microbiology nucleic acid amplification (NAT) assays1 report
- APTIMA AC2, REFRIG, 250T, READY MADEDNA-REAGENTS, NEISSERIA1 report
- APTIMA PANTHER,TRICH REFRIG,V2,250T,READY MADETrichomonas vaginalis nucleic acid amplification test system1 report
- Aptima® APTIMA URINE SPECIMEN COLLECTION KITInstrumentation for clinical multiplex test systems1 report
Recent Aptima adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 5, 2026False Negative Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50625130 ↗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 ↗InjuryJun 16, 2026Insufficient Device Problem Information
ON (B)(6) 2026, A CUSTOMER IN CANADA CONTACTED HOLOGIC TO REPORT ERGONOMIC CONCERNS ON THEIR OPERATORS. ON (B)(6) 2026, HOLOGIC RECEIVED CLARIFICATION THAT THREE OPERATORS AT THE CUSTOMER SITE SUSTAINED ERGONOMIC INJURIES DUE TO SPECIMEN RACK HANDLING ON THE INSTRUMENT, ADDING AND/OR REMOVING SAMPLE TUBES, AND CAPPING OR UNCAPPING SPECIMEN TUBES. THE INJURIES REPORTED INCLUDED TINGLING AND NUMBNESS IN THE HANDS, PAIN IN THE ELBOW, AND A HAND INJURY. DUE TO THESE INJURIES, THE OPERATORS WERE UNABLE TO PERFORM SOME OF THESE LAB TASKS. THE CUSTOMER REPORTED THE INJURIES INTERNALLY TO THE INJURY NEAR MISS (INM) SHARED HEALTH AND EXTERNALLY TO THE WORKERS¿ COMPENSATION BOARD (WCB). THE CUSTOMER DID NOT PROVIDE FURTHER DETAILS ABOUT THE INJURIES, ANY MEDICAL INTERVENTION OR THE MEDICAL STATUS OF THE INJURED OPERATORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25522051 ↗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 ↗InjuryMar 30, 2026False Negative Result
ON (B)(6) 2026, A CUSTOMER IN CANADA REPORTED TO HOLOGIC THAT THEY HAD DISCREPANT RESULTS FOR 2 ALIQUOTS OF THE SAME SOURCE SAMPLE TESTED IN TRIPLICATE WITH THE APTIMA HPV ASSAY KIT RUN ON THE PANTHER PLUS INSTRUMENT SN: (B)(6). ON (B)(6) 2026, WHILE PERFORMING A NEW ASSAY KIT LOT VALIDATION, SAMPLE ID: (B)(6) WAS TESTED USING HPV ASSAY KIT MASTER LOT (ML) 921025 AND INITIALLY RESULTED HPV POSITIVE, THEN POSITIVE AND NEGATIVE UPON RETESTING IN WORKLIST ID: (B)(4). SAMPLE ID: (B)(6) WAS TESTED USING HPV ASSAY KIT ML 927271 AND INITIALLY RESULTED HPV POSITIVE, THEN NEGATIVE AND NEGATIVE UPON RETESTING IN WORKLIST ID: (B)(4). THE CUSTOMER EXPECTED THE RESULT TO BE NEGATIVE BASED ON PREVIOUS TESTING. LOGS FOR PREVIOUS TESTS WERE NOT PROVIDED, AND IT IS NOT CLEAR WHETHER THESE PREVIOUS RUNS WERE USING THE SAME SAMPLE TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24732950 ↗InjuryMar 13, 2026False Negative Result
ON (B)(6) 2026, CUSTOMER REPORTED TO HOLOGIC USING IMPROPERLY RECONSTITUTED APTIMA TRICHOMONAS VAGINALIS (ATV) ASSAY REAGENTS. THE ATV KIT WAS RECONSTITUTED ON FEBRUARY 13, 2026, WITH THE REFRIGERATED COMPONENTS FROM MASTER LOT: 919757 AND THE ROOM TEMPERATURE COMPONENTS FROM ML 925885. THIS ATV KIT WAS THEN USED FOR TESTING OF PATIENT SAMPLES ON WL (B)(4) ON PANTHER SN#: (B)(6). THIS IS CONSIDERED OFF-LABEL USE OF THE ATV ASSAY. IT IS NOT KNOWN WHETHER THE RESULTS HAVE BEEN REPORTED OR IF THE SAMPLES WILL BE RETESTED OR RECOLLECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24592006 ↗
Other Hologic, Inc. products
- BioZorb9 models · 326 reports · 3 recalls
- Selenia Dimensions9 models · 245 reports · 3 recalls
- NovaSure5 models · 344 reports
- Brevera Breast Biopsy System5 models · 300 reports
- 3Dimensions9 models · 67 reports · 3 recalls
- NovaSure SureSound2 models · 182 reports
- Panther Fusion3 models · 9 reports · 3 recalls
- Sertera Biopsy Device2 models · 16 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page