Aptima® KIT, APTIMA HPV 16 18/45, 100 REF IVDRecalls & reported problems
Hologic, Inc. · Aptima® HPV 16 18/45 Genotype Assay, 100 test, box 1 of 2 (2°C to 8°C box). · Class 3
All models of Aptima (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15420045500112), received between Feb 10, 2026 and Feb 10, 2026 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Imprecise or Erratic Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 10, 2026Imprecise or Erratic Results
ON (B)(6) 2026, CUSTOMER REPORTED THAT THEY RECEIVED DISCREPANT RESULTS ON THREE SAMPLES IDS (SIDS) (B)(6) WHILE RUNNING THE APTIMA HPV 16 18/45 GENOTYPE (AHPV-GT) ASSAY (ML 920131) ON THEIR PANTHER PLUS INSTRUMENT (SN: (B)(6). ON (B)(6) 2026, CUSTOMER INITIALLY TESTED ALL THREE SAMPLES ON AHPV-GT WORKLIST (WL) (B)(4) AND RECEIVED VALID HPV 16 NEGATIVE AND HPV 18/45 NEGATIVE RESULTS FOR THESE SAMPLES. DUE TO POTENTIAL REAGENT KIT PREPARATION ISSUES WITH THE INITIAL WORKLIST, CUSTOMER LATER RETESTED ALL SAMPLES FROM WL (B)(4) USING THE SAME SAMPLE TUBE ON (B)(6) 2026, WITH WL (B)(4) USING A NEW REAGENT KIT ON THE SAME PANTHER INSTRUMENT. SIDS (B)(6) RESULTED HPV 16 POSITIVE AND HPV 18/45 NEGATIVE UPON RETEST, WHILE SID (B)(6) RESULTED HPV 16 NEGATIVE AND HPV 18/45 POSITIVE ON RETEST. IN ADDITION, CUSTOMER ALSO TESTED NEW ALIQUOTS OF THESE SAMPLES IN WL (B)(4). NEW ALIQUOTS OF SIDS (B)(6) RESULTED HPV 16 POSITIVE AND HPV 18/45 NEGATIVE AND NEW ALIQUOT OF SID (B)(6) RESULTED HPV 16 NEGATIVE AND HPV 18/45 POSITIVE. CUSTOMER DID NOT CONFIRM WHICH SAMPLE RESULTS WERE REPORTED OUT OR AMENDED NOR DID CUSTOMER PROVIDE ANY INFORMATION ON PATIENTS OR PATIENT TREATMENT. HOLOGIC HAS NOT BEEN IN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24308439 ↗
Other Kit, rna detection, human papillomavirus devices
- Aptima® KIT, HPV, APTIMA, 250 TEST, REFRIG, IVDHologic, Inc. · Kit, rna detection, human papillomavirus1 recall32 reports
- Aptima® KIT,HPV,APTIMA,250 TEST,ROOM TEMP, IVDHologic, Inc. · Kit, rna detection, human papillomavirus1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
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