Aptima® KIT, HPV, APTIMA, 250 TEST, REFRIG, IVDRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 15420045500051), received between Sep 11, 2018 and Mar 30, 2026 — classified as 28 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Imprecise or Erratic Results” (24 reports).

1 FDA recall record name this device's identifier, 1 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, 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 16, 2026.

Recalls naming this device

1. Feb 18, 2026Open, Classified

   Due to product exhibiting potential to generate either invalid or false negative results.

   Z-1586-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryDec 22, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC DISCREPANT RESULTS FOR SAMPLE ID¿S (SID) (B)(6) WHILE USING THE APTIMA HPV ASSAY ML 919387 ON THEIR PANTHER PLUS INSTRUMENT (SN (B)(6)). ON (B)(6) 2025, THE CUSTOMER INITIALLY TESTED THESE SID ON WORKLIST (WL) (B)(4) AND RECEIVED A POSITIVE RESULT FOR SID (B)(6), AND A NEGATIVE RESULT FOR SID (B)(6). PER CUSTOMER LAB POLICY, A POSITIVE RESULT MUST BE MANUALLY APPROVED, AND A NEGATIVE RESULT GETS REPORTED AUTOMATICALLY. ON (B)(6) 2025, THE CUSTOMER RETESTED THESE SAMPLES IN WL (B)(4) ON A DIFFERENT PANTHER INSTRUMENT (SN (B)(6)) AND RECEIVED DISCREPANT RESULTS: SID (B)(6) AND SID (B)(6) TESTED NEGATIVE AND SID (B)(6) TESTED POSITIVE. CUSTOMER CONFIRMED THE HPV NEGATIVE RESULTS WERE REPORTED OUT. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866139 ↗
• InjuryAug 29, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC A DISCREPANT RESULT USING APTIMA HPV ASSAY MASTER LOT 915392 WHEN TESTING A SAMPLE ON PANTHER INSTRUMENT SERIAL NUMBER (B)(6). ON (B)(6) 2025, SAMPLE SID (B)(6) WAS TESTED ON HPV (B)(4) AND RESULTED HPV NEGATIVE WITH AN S/CO VALUE OF 0.00. CUSTOMER REPORTED THIS RESULT TO THE PHYSICIAN/PATIENT. CUSTOMER NOTED THAT THIS SAMPLE WAS ACCIDENTALLY LEFT ON THE INSTRUMENT AND RUN AGAIN ON THE SAME WORKLIST THE NEXT DAY. ON (B)(6) 2025, SAMPLE SID (B)(6) RESULTED HPV POSITIVE WITH AN S/CO VALUE OF 5.26. ON (B)(6) 2025, THE SAME SAMPLE WAS RETESTED ON HPV (B)(4) AND RESULTED HPV POSITIVE AGAIN WITH AN S/CO VALUE OF 5.97. CUSTOMER NOTED THAT ALL 3 TESTS WERE PERFORMED WITH THE SAME SAMPLE TUBE. THE RESULT WAS AMENDED TO INDETERMINATE AND CUSTOMER REQUESTED FOR A NEW SAMPLE TO BE RECOLLECTED. CUSTOMER WAS NOT AWARE OF ANY PATIENT TREATMENT. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22925711 ↗
• InjuryAug 19, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC A DISCREPANT RESULT ON PANTHER INSTRUMENT (SERIAL NUMBER: (B)(6) USING THE APTIMA HPV (HUMAN PAPILLOMAVIRUS) ASSAY (MASTER LOT: 909954). THE CUSTOMER REPORTED THAT PER LAB IQA PROCEDURES, THEY SELECT RANDOM SAMPLES TO RETEST. ON (B)(6) 2025, SAMPLE (B)(6) INITIALLY RESULTED HPV NEGATIVE UNDER WORKLIST(B)(4). ON THE SAME DAY, THE SAME SAMPLE WAS RETESTED AS SAMPLE ID (B)(6) UNDER WORKLIST (B)(4) AND RESULTED HPV POSITIVE. ON (B)(6) 2025, THE CUSTOMER DECIDED TO RETEST THE SAMPLE (B)(6) FROM THE ORIGINAL THINPREP VIAL AND SAMPLE RESULTED POSITIVE UNDER WORKLIST (B)(4). THE CUSTOMER REPORTED THE FIRST VALID RESULT (NEGATIVE RESULT FROM (B)(6) 2025). HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840306 ↗
• InjuryAug 4, 2025Off-Label Use; Off-Label Use

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED A DISCREPANT RESULT USING APTIMA COMBO 2 ASSAY (AC2) MASTER LOT 919672 WHEN TESTING A SAMPLE ON PANTHER PLUS INSTRUMENTS. ON (B)(6) 2025, SAMPLE ID # (B)(6) WAS TESTED ON (B)(4) ON PANTHER PLUS SERIAL NUMBER (B)(6) AND THE SAMPLE RESULTED CT POSITIVE & GC POSITIVE. THE NEXT DAY THE CUSTOMER RETESTED THE SAME SAMPLE PER THEIR OWN INTERNAL SOP, ON (B)(4) ON PANTHER PLUS INSTRUMENT SERIAL NUMBER (B)(6) AND THE SAMPLE RESULTED CT NEGATIVE & GC NEGATIVE. CUSTOMER NOTED THE RETEST RESULTS (CT NEGATIVE & GC NEGATIVE) WERE REPORTED TO THE PHYSICIAN/PATIENT. CUSTOMER NOTED THAT THE PATIENT RECEIVED NO TREATMENT DUE TO THE REPORTED RESULTS. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22708628 ↗
• InjuryJul 18, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS USING APTIMA HPV ASSAY (MASTER LOT 916336) ON PANTHER PLUS INSTRUMENT (SERIAL NUMBER (B)(6). ON (B)(6) 2025, FOLLOWING SERVICE ON THEIR PANTHER PLUS INSTRUMENT (SN (B)(6), CUSTOMER DECIDED TO PERFORM A VERIFICATION RUN USING 10 SAMPLES THAT PREVIOUSLY RESULTED HPV POSITIVE AND 10 SAMPLES THAT PREVIOUSLY RESULTED HPV NEGATIVE. TWO OF THE INITIAL HPV POSITIVE SAMPLES (SAMPLE IDS (B)(6) RESULTED AS HPV NEGATIVE ON HPV. (B)(6). ON (B)(6) 2025, THE CUSTOMER OPTED TO PERFORM ANOTHER RETEST ON THESE SAMPLE IDS: (B)(6), ALONGSIDE AN ADDITIONAL 5 SAMPLE IDS THAT INITIALLY TESTED HPV POSITIVE AND 5 SAMPLE IDS THAT INITIALLY TESTED HPV NEGATIVE. SAMPLE ID (B)(6) RESULTED HPV NEGATIVE, WHILE SAMPLE ID (B)(6) RESULTED HPV POSITIVE ON HPV (B)(6). OF THE ADDITIONAL 5 HPV POSITIVE SAMPLES RETESTED, 2 (SAMPLE IDS: (B)(6) PRODUCED HPV NEGATIVE RESULTS. FOR ALL THESE SAMPLES, THE INITIAL POSITIVE RESULTS WERE REPORTED AND THE RETEST RESULTS WERE NOT REPORTED. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22547284 ↗
• InjuryJun 2, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON 5/7/25, A CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS USING THE APTIMA HPV (HUMAN PAPILLOMAVIRUS) ASSAY MASTER LOT 908328 ON THE PANTHER INSTRUMENT SN# (B)(6). SAMPLE ID # (B)(6) WAS PART OF A CLUSTER AND INITIALLY RESULTED HPV POSITIVE (HPV WORKLIST NOT PROVIDED). PER THE CUSTOMER¿S LAB SOP, IF THERE IS A CLUSTER OF THREE HPV POSITIVES CONTAINING RESULTS WITH AN S/CO (SIGNAL-TO-CUTOFF) VALUE < 5, THE SAMPLES WITH S/CO<5 WILL BE RETESTED, AND THE RETESTED RESULT WILL BE REPORTED OUT. UPON RETEST, SAMPLE ID # (B)(6) RESULTED HPV NEGATIVE, AND THIS RESULT WAS REPORTED OUT. NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125112 ↗
• InjuryJun 2, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS USING THE APTIMA HPV (HUMAN PAPILLOMAVIRUS) ASSAY MASTER LOT 908328 ON THE PANTHER INSTRUMENT SN# (B)(6). SAMPLE IDS # (B)(6) WERE PART OF A CLUSTER AND INITIALLY RESULTED HPV POSITIVE IN HPV WORKLIST # (B)(4). PER THE CUSTOMER¿S LAB SOP, IF THERE IS A CLUSTER OF THREE HPV POSITIVES CONTAINING RESULTS WITH AN S/CO (SIGNAL-TO-CUTOFF) VALUE < 5, THE SAMPLES WITH S/CO<5 WILL BE RETESTED, AND THE RETESTED RESULT WILL BE REPORTED OUT. UPON RETEST, SAMPLE IDS # (B)(6) RESULTED HPV NEGATIVE AND (B)(6) RESULTED HPV POSITIVE, AND THESE RESULTS WERE REPORTED OUT. SAMPLE IDS # (B)(6) WERE NOT RETESTED AS THESE SAMPLES RESULTED HPV POSITIVE WITH AN S/CO > 5. NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124857 ↗
• InjuryJun 2, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON 5/7/25, A CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS USING THE APTIMA HPV (HUMAN PAPILLOMAVIRUS) ASSAY MASTER LOT 908328 ON THE PANTHER INSTRUMENT SN# (B)(6). SAMPLE IDS # (B)(6) WAS PART OF A CLUSTER AND INITIALLY RESULTED HPV POSITIVE (HPV WORKLIST NOT PROVIDED). PER THE CUSTOMER¿S LAB SOP, IF THERE IS A CLUSTER OF THREE HPV POSITIVES CONTAINING RESULTS WITH AN S/CO (SIGNAL-TO-CUTOFF) VALUE < 5, THE SAMPLES WITH S/CO<5 WILL BE RETESTED, AND THE RETESTED RESULT WILL BE REPORTED OUT. UPON RETEST, SAMPLE ID # (B)(6) RESULTED HPV NEGATIVE, AND THIS RESULT WAS REPORTED OUT. NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124469 ↗
• InjuryJun 2, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS USING THE APTIMA HPV (HUMAN PAPILLOMAVIRUS) ASSAY MASTER LOT ON PANTHER PLUS INSTRUMENT SN# (B)(6). SAMPLE IDS # (B)(6) WERE PART OF A CLUSTER AND INITIALLY RESULTED HPV POSITIVE IN HPV WL # (B)(4). PER THE CUSTOMER¿S LAB SOP, IF THERE IS A CLUSTER OF THREE HPV POSITIVES CONTAINING RESULTS WITH AN S/CO (SIGNAL-TO-CUTOFF) VALUE < 5, THE SAMPLES WITH S/CO<5 WILL BE RETESTED, AND THE RETESTED RESULT WILL BE REPORTED OUT. UPON RETEST, SAMPLE ID #(B)(6) RESULTED HPV NEGATIVE AND SAMPLE ID #(B)(6) RESULTED POSITIVE, AND THESE RESULTS WERE REPORTED OUT. SAMPLE ID # (B)(6) WAS NOT RETESTED AS THIS SAMPLE RESULTED HPV POSITIVE WITH AN S/CO > 5. NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124188 ↗
• InjuryMay 30, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS USING THE APTIMA HPV (HUMAN PAPILLOMAVIRUS) ASSAY MASTER LOT 908328 ON PANTHER PLUS INSTRUMENT SN# (B)(6). SAMPLE IDS # (B)(6) WERE PART OF A CLUSTER AND INITIALLY RESULTED HPV POSITIVE IN HPV WORKLIST # (B)(4). PER CUSTOMER¿S LAB SOP, IF THERE IS A CLUSTER OF THREE HPV POSITIVES CONTAINING RESULTS WITH AN S/CO (SIGNAL-TO-CUTOFF) VALUE < 5, THE SAMPLES WITH S/CO<5 WILL BE RETESTED, AND THE RETESTED RESULT WILL BE REPORTED OUT. UPON RETEST, SAMPLE ID # (B)(6) RESULTED HPV NEGATIVE, AND THIS RESULT WAS REPORTED OUT. SAMPLE IDS # (B)(6) WERE NOT RETESTED AS THESE SAMPLES RESULTED HPV POSITIVE WITH AN S/CO > 5. NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22119528 ↗
• InjuryMay 30, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS USING THE APTIMA HPV (HUMAN PAPILLOMAVIRUS) ASSAY MASTER LOT 907848 ON THE PANTHER INSTRUMENT SN# (B)(6). SAMPLE IDS # (B)(6) WERE PART OF A CLUSTER AND INITIALLY RESULTED HPV POSITIVE IN HPV WL #(B)(6). PER THE CUSTOMER¿S LAB SOP, IF THERE IS A CLUSTER OF THREE HPV POSITIVES CONTAINING RESULTS WITH AN S/CO (SIGNAL-TO-CUTOFF) VALUE < 5, THE SAMPLES WITH S/CO<5 WILL BE RETESTED, AND THE RETESTED RESULT WILL BE REPORTED OUT. UPON RETEST, SAMPLE IDS #(B)(6) RESULTED HPV NEGATIVE, AND THIS RESULT WAS REPORTED OUT. SAMPLE IDS # (B)(6) WERE NOT RETESTED AS THESE SAMPLES RESULTED HPV POSITIVE WITH AN S/CO > 5. NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22119518 ↗
• InjuryMay 27, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS USING THE APTIMA HPV (HUMAN PAPILLOMAVIRUS) ASSAY MASTER LOT 907848 ON PANTHER PLUS INSTRUMENT SN# (B)(6). SAMPLE IDS #(B)(6) WERE PART OF A CLUSTER AND INITIALLY RESULTED HPV POSITIVE IN (B)(4). PER CUSTOMER¿S LAB SOP, IF THERE IS A CLUSTER OF THREE HPV POSITIVES CONTAINING RESULTS WITH AN S/CO (SIGNAL-TO-CUTOFF) VALUE < 5, THE SAMPLES WITH S/CO<5 WILL BE RETESTED AND THE RETESTED RESULT WILL BE REPORTED OUT. UPON RETEST, SAMPLE ID # (B)(6) RESULTED HPV NEGATIVE. SAMPLE IDS # (B)(6) WERE NOT RETESTED AS THESE SAMPLES RESULTED HPV POSITIVE WITH AN S/CO > 5. NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22092866 ↗
• InjuryMay 23, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS USING THE APTIMA HPV (HUMAN PAPILLOMAVIRUS) ASSAY MASTER LOT 908328 ON PANTHER PLUS INSTRUMENT SN (B)(6). SAMPLE ID (B)(6) WAS PART OF A CLUSTER AND INITIALLY RESULTED HPV POSITIVE ON (B)(4). PER THE CUSTOMER¿S LAB SOP, IF THERE IS A CLUSTER OF THREE HPV POSITIVE RESULTS WITH AN S/CO (SIGNAL-TO-CUTOFF) VALUE < 5, THESE SAMPLES WILL BE RETESTED, AND THE RETESTED RESULT WILL BE REPORTED OUT. UPON RETEST, SAMPLE ID (B)(6) RESULTED HPV NEGATIVE ON (B)(4) NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081172 ↗
• InjuryMay 23, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON 05/07/2025, A CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS USING THE APTIMA HPV (HUMAN PAPILLOMAVIRUS) ASSAY MASTER LOT 908328 ON PANTHER PLUS INSTRUMENT SN (B)(6). SAMPLE ID (B)(6) WAS PART OF A CLUSTER AND INITIALLY RESULTED HPV POSITIVE ON HPV (B)(6). PER THE CUSTOMER¿S LAB SOP, IF THERE IS A CLUSTER OF THREE HPV POSITIVE RESULTS WITH AN S/CO (SIGNAL-TO-CUTOFF) VALUE < 5, THESE SAMPLES WILL BE RETESTED, AND THE RETESTED RESULT WILL BE REPORTED OUT. UPON RETEST, SAMPLE ID (B)(6) RESULTED HPV NEGATIVE ON HPV (B)(6). NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081067 ↗
• InjuryMay 23, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS USING THE APTIMA HPV (HUMAN PAPILLOMAVIRUS) ASSAY MASTER LOT 908328 ON PANTHER PLUS INSTRUMENT SN (B)(6). SAMPLE ID (B)(6) WERE BOTH PART OF A CLUSTER AND INITIALLY RESULTED HPV POSITIVE ON (B)(4). PER THE CUSTOMER¿S LAB SOP, IF THERE IS A CLUSTER OF THREE HPV POSITIVE RESULTS WITH AN S/CO (SIGNAL-TO-CUTOFF) VALUE < 5, THESE SAMPLES WILL BE RETESTED, AND THE RETESTED RESULT WILL BE REPORTED OUT. UPON RETEST, SAMPLE ID (B)(6) BOTH RESULTED HPV NEGATIVE ON (B)(4). NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080982 ↗
• InjuryMay 23, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS USING THE APTIMA HPV (HUMAN PAPILLOMAVIRUS) ASSAY MASTER LOT 908328 ON PANTHER PLUS INSTRUMENT SN (B)(6). SAMPLE ID (B)(6) WAS PART OF A CLUSTER AND INITIALLY RESULTED HPV POSITIVE ON (B)(4). PER THE CUSTOMER¿S LAB SOP, IF THERE IS A CLUSTER OF THREE HPV POSITIVE RESULTS WITH AN S/CO (SIGNAL-TO-CUTOFF) VALUE < 5, THESE SAMPLES WILL BE RETESTED, AND THE RETESTED RESULT WILL BE REPORTED OUT. UPON RETEST, SAMPLE ID (B)(6) RESULTED HPV NEGATIVE ON (B)(4). NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080899 ↗
• InjuryMay 23, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS USING THE APTIMA HPV (HUMAN PAPILLOMAVIRUS) ASSAY MASTER LOT 908328 ON PANTHER PLUS INSTRUMENT SN (B)(6). SAMPLE ID (B)(6) WAS PART OF A CLUSTER AND INITIALLY RESULTED HPV POSITIVE ON HPV WL-010823-20250302-33. PER THE CUSTOMER¿S LAB SOP, IF THERE IS A CLUSTER OF THREE HPV POSITIVE RESULTS WITH AN S/CO (SIGNAL-TO-CUTOFF) VALUE < 5, THESE SAMPLES WILL BE RETESTED, AND THE RETESTED RESULT WILL BE REPORTED OUT. UPON RETEST, SAMPLE ID (B)(6) RESULTED HPV NEGATIVE ON HPV WL-010793-20250303-07. NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080699 ↗
• InjuryMay 23, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS USING THE APTIMA HPV (HUMAN PAPILLOMAVIRUS) ASSAY MASTER LOT 908328 ON PANTHER PLUS INSTRUMENT SN (B)(6). SAMPLE ID (B)(6) WERE BOTH PART OF A CLUSTER AND INITIALLY RESULTED HPV POSITIVE ON (B)(4). PER THE CUSTOMER¿S LAB SOP, IF THERE IS A CLUSTER OF THREE HPV POSITIVE RESULTS WITH AN S/CO (SIGNAL-TO-CUTOFF) VALUE < 5, THESE SAMPLES WILL BE RETESTED, AND THE RETESTED RESULT WILL BE REPORTED OUT. UPON RETEST, SAMPLE ID (B)(6) BOTH RESULTED HPV NEGATIVE ON (B)(4). NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080647 ↗
• InjuryMay 15, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, CUSTOMER REPORTED 7 DISCREPANT RESULTS USING APTIMA HPV ASSAY ON PANTHER FUSION INSTRUMENTS. ALL 7 SAMPLES WERE INITIALLY RUN IN HPV WORKLIST 003175-20250423-02 USING APTIMA HPV ASSAY (ML: 911442) ON PANTHER FUSION INSTRUMENT (SN: (B)(6). FOUR SAMPLES RESULTED HPV POSITIVE (SAMPLE ID# (B)(6), WHILE THE OTHER 3 SAMPLES RESULTED HPV NEGATIVE (SAMPLE ID# (B)(6). CUSTOMER RETESTED THE SAMPLES IN HPV WORKLIST 002809-20250425 USING APTIMA HPV ASSAY (ML: 908328) ON PANTHER INSTRUMENT (SN:(B)(6) AND OBTAINED DISCREPANT RESULTS FOR EACH SAMPLE: THE 4 INITIAL HPV POSITIVE SAMPLES RESULTED HPV NEGATIVE AND THE 3 INITIAL HPV NEGATIVE SAMPLES RESULTED HPV POSITIVE. CUSTOMER THEN RETESTED THE SAME SAMPLES AGAIN IN HPV WORKLIST 002640-20250427-11 USING APTIMA HPV ASSAY (ML: 911623) ON PANTHER FUSION INSTRUMENT (SN: (B)(6) AND OBTAINED 2 DISCREPANT RESULTS COMPARED TO THE RETESTED RESULTS: SAMPLE ID# (B)(6) RETESTED HPV POSITIVE AND SAMPLE ID# (B)(6) RETESTED HPV NEGATIVE. CUSTOMER DECIDED TO REPORT 2 OF THE SAMPLES (SAMPLE ID# (B)(6), AS HPV POSITIVE AND THE 5 OTHER SAMPLES AS HPV NEGATIVE TO PHYSICIANS/PATIENTS. CUSTOMER DID NOT PROVIDE ANY PATIENT TREATMENT INFORMATION. HOLOGIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22028618 ↗
• InjuryMay 8, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON APRIL 15TH, 2025, CUSTOMER REPORTED 8 DISCREPANT RESULTS USING APTIMA HPV ASSAY ON PANTHER PLUS INSTRUMENT. ALL 8 SAMPLES WERE INITIALLY RAN ON HPV WORKLIST (B)(4) USING APTIMA HPV ASSAY (ML: 912703) ON PANTHER PLUS INSTRUMENT (SN: (B)(6)), AND 3 SAMPLES RESULTED HPV POSITIVE WHILE THE OTHER 5 SAMPLES RESULTED HPV NEGATIVE. CUSTOMER NOTED THAT THE INITIAL RESULTS WERE REPORTED TO PATIENTS. CUSTOMER RETESTED THE ORIGINAL 8 SAMPLES ACROSS 4 DIFFERENT HPV WORKLISTS (B)(4) ON PANTHER PLUS INSTRUMENTS (SNS: (B)(6)) AND OBTAINED FLIPPED DISCREPANT RESULTS FOR EACH SAMPLE (THE 5 INITIALLY HPV NEGATIVE SAMPLES RESULTED HPV POSITIVE WHILE THE 3 INITIALLY HPV POSITIVE SAMPLES RESULTED HPV NEGATIVE). CUSTOMER AMENDED THE 5 SAMPLES THAT INITIALLY RESULTED HPV NEGATIVE TO HPV POSITIVE. CUSTOMER DID NOT PROVIDE ANY PATIENT TREATMENT INFORMATION. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21987815 ↗
• InjuryMar 28, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6), 2025, CUSTOMER REPORTED A DISCREPANT RESULT USING APTIMA HPV ASSAY ON PANTHER INSTRUMENT. THE SAMPLE WAS INITIALLY RAN ON HPV WORKLIST (B)(4) USING THE APTIMA HPV ASSAY (ML: (B)(6)) AND RESULTED HPV NEGATIVE. CUSTOMER NOTED THE INITIAL HPV NEGATIVE RESULT WAS REPORTED OUT AND QUESTIONED BY THE PHYSICIAN. CUSTOMER RETESTED DIFFERENT ALIQUOTS AS WELL AS THE ORIGINAL SAMPLE ON HPV WORKLIST (B)(4) ON PANTHER INSTRUMENT SN# (B)(6) USING THE APTIMA HPV ASSAY (ML: 908238) AND OBTAINED HPV POSITIVE RESULTS EACH TIME. CUSTOMER SUBSEQUENTLY AMENDED THE RESULT TO HPV POSITIVE. CUSTOMER DID NOT PROVIDE ANY PATIENT TREATMENT INFORMATION. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21725587 ↗
• InjuryMar 20, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON FEBRUARY 25, 2025, A CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED DISCREPANT RESULTS USING APTIMA HPV (HUMAN PAPILLOMAVIRUS) ASSAY MASTER LOT 906554 ON THE PANTHER INSTRUMENT. SAMPLE ID # (B)(6) WAS TESTED IN DUPLICATE ON HPV WORKLIST 002503-002531-20250221-11, RESULTING IN ONE NEGATIVE RESULT AND ONE POSITIVE RESULT. THE CUSTOMER RETESTED THE SAMPLE WITH AN UNKNOWN METHOD/TEST AND THE RETEST RESULTED POSITIVE. THE CUSTOMER REVIEWED THE PATIENT'S MEDICAL HISTORY AND OTHER CLINICAL DATA (CYTOLOGY) AND DECIDED ON REPORTING THE HPV POSITIVE RESULT TO THE CAREGIVER/PATIENT. NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21654203 ↗
• InjuryJan 31, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, CUSTOMER REPORTED A DISCREPANT RESULT USING APTIMA HPV SCREENING ASSAY (ML 905627), WORKLIST: (B)(4), ON PANTHER PLUS INSTRUMENT SERIAL NUMBER: (B)(6). CUSTOMER NOTED THE SAMPLE WAS RAN IN DUPLICATE ON THE SAME WORKLIST AND PRODUCED BOTH A NEGATIVE AND POSITIVE RESULT. CUSTOMER RETESTED THE SAME SAMPLE USING WORKLIST: (B)(4) ON PANTHER INSTRUMENT SERIAL NUMBER: (B)(6) AND OBTAINED A NEGATIVE RESULT. CUSTOMER NOTED THAT THEY WOULD REPORT THE NEGATIVE RESULT TO THE PATIENT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289082 ↗
• InjuryAug 9, 2024Imprecise or Erratic Results; Imprecise or Erratic Results

  ON JULY 10, 2024, ONE CUSTOMER REPORTED TO HOLOGIC THAT THEY HAD THREE DISCREPANT RESULTS USING THE APTIMA HPV ASSAY (LOT 895916) ON THE PANTHER INSTRUMENT. THE CUSTOMER HAD BEEN USING HPV NEGATIVE CALIBRATORS AS AN EXTERNAL QUALITY CONTROL (EQC), THAT RESULTED POSITIVE WHILE USING MASTER LOT (ML) 895916. DUE TO THE INITIAL EQC RESULT, THE CUSTOMER DECIDED TO RETEST ALL SAMPLES USING THE SAME ALIQUOT AND RECEIVED THREE NEGATIVE RESULTS UPON RETEST. HOLOGIC TECHNICAL SUPPORT INFORMED THE CUSTOMER THAT HPV CALIBRATORS ARE SINGLE-USE TUBES AND ARE NOT TO BE REUSED AS AN EQC. THE CUSTOMER DECIDED TO WITHHOLD THE RESULTS DUE TO INITIAL EQC RESULT, AND REPORTED THE NEGATIVE RESULTS TO THE PATIENTS ACCORDINGLY. NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19952879 ↗