APTIMA® KIT, MAIN ASSAY, HIV QUANT, 100T, US IVDRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 15420045504219), received between Dec 13, 2024 and Aug 27, 2025 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Imprecise or Erratic Results” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  FOLLOW-UP REPORT. SEE SECTION H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22906624 ↗
• InjuryAug 7, 2025False Positive Result; False Positive Result

  ON (B)(6) 2025, A CUSTOMER IN FRANCE REPORTED TO HOLOGIC A DISCREPANT RESULT WAS GENERATED WHILE USING THE APTIMA HIV-1 QUANT DX ASSAY (MASTER LOT 899574) WITH PANTHER INSTRUMENT SERIAL NUMBER: (B)(6). THE CUSTOMER NOTED THAT SAMPLE ID (B)(6), WHICH WAS FIRST TESTED IN PANTHER WORKLIST ID (B)(6) ON (B)(6), 2025, GENERATED A VALID HIV-1 "DETECTED" RESULT WITH 7,201,348 COPIES/ML. PER THE CUSTOMER, THE HIV-1 "DETECTED" RESULT WAS REPORTED OUT TO THE TREATING PHYSICIAN OF THE PATIENT. THE PATIENT WAS A KNOWN HIV-INFECTED MALE. ALLEGEDLY, THIS PATIENT WAS KNOWN TO NOT STRICTLY ADHERE TO HIS PRESCRIBED TREATMENT PLAN. WITH THE AIM OF FOLLOWING UP ON DISEASE PROGRESSION, A NEW SAMPLE WAS REQUESTED TO BE COLLECTED". A NEW SAMPLE WAS COLLECTED FROM THE PATIENT ON (B)(6) 2025. THE SAMPLE ID (B)(6) WAS ANALYZED THE SAME DAY USING APTIMA HIV-1 QUANT DX ASSAY (MASTER LOT 899574) ON PANTHER INSTRUMENT SERIAL NUMBER: (B)(6). THE SAMPLE WAS TESTED UNDER PANTHER WORKLIST ID (B)(6) AND GENERATED A VALID HIV-1 " DETECTED" RESULT WITH <30 COPIES/ML. THE DISCREPANCY BETWEEN THESE RESULTS PROMPTED THE OPERATOR TO REPEAT BOTH THE ORIGINAL SAMPLE ID (B)(6), NOW IDENTIFIED AS SAMPLE ID (B)(6) AS WELL AS T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22744213 ↗
• InjuryAug 5, 2025False Positive Result; False Positive Result

  ON JULY 18, 2025, A CUSTOMER REPORTED TO HOLOGIC THAT THE PANTHER INSTRUMENT (SERIAL NUMBER: (B)(6)) HAD A DISCREPANT APTIMA HIV RESULT USING THE APTIMA HIV-1 QUANT DX ASSAY (ML: 896020) UNDER WORKLIST (B)(4). THE CUSTOMER REPORTED THAT THE FIRST RUN OF THE SAMPLE PRODUCED A POSITIVE SIGNAL. THIS RESULT WAS QUESTIONED BASED ON PATIENT HISTORY. THE CUSTOMER ALSO QUESTIONED THE RESULT AS THEY RECOGNIZED AN LTR SIGNAL ARISING VERY EARLY BEFORE RAPIDLY RETURNING TO ZERO. THE CUSTOMER DECIDED TO REPEAT THE SAMPLE BEFORE REPORTING OUT THE POSITIVE RESULT. THE RETEST OF THE SAMPLE WAS NEGATIVE, AND THIS NEGATIVE RESULT WAS 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 22715666 ↗
• InjuryJul 16, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER REPORTED QUESTIONING RESULTS USING THE APTIMA HIV-1 QUANT DX ASSAY MASTER LOT: 896020 ON PANTHER PLUS INSTRUMENT SN#: (B)(6). THE CUSTOMER NOTED SAMPLE ID: (B)(6) WAS TESTED IN PANTHER WORKLIST: 000940-20250606-03 AND RESULTED WITH >10,000,000 COPIES/ML BUT THE SAMPLE CURVE WAS POOR. ON (B)(6) 2025, THE CUSTOMER STATED THAT THEY HAVE NO REMAINING SAMPLE LEFT FOR RETESTING AS THE REMAINING SAMPLE WAS SENT TO THE REFERENCE LABORATORY FOR TESTING. THE REFERENCE LABORATORY WAS UNABLE TO AMPLIFY ANY PRODUCT. ON (B)(6) 2025, CUSTOMER STATED THAT THE >10,000,000 COPIES/ML RESULT WAS REPORTED OUT TO THE CONSULTANT. NO INFORMATION REGARDING PATIENT TREATMENT WAS PROVIDED. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523575 ↗
• InjuryJun 30, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON JUNE 5, 2025, A CUSTOMER REPORTED QUESTIONING RESULTS USING THE APTIMA HIV-1 QUANT DX ASSAY MASTER LOT 911588 ON PANTHER PLUS INSTRUMENT SN# (B)(6). THE CUSTOMER NOTED THAT SAMPLES FROM THE PATIENT WERE COLLECTED IN BOTH SERUM SEPARATOR TUBES (SST) AND PLASMA PREPARATION TUBES (PPT). THE DISCREPANT RESULTS ARE AS FOLLOWS: SAMPLE ID (B)(6) RETESTED AS (B)(6): ¿ ON (B)(6) 2025, THE SST WAS FIRST TESTED IN PANTHER WORKLIST: (B)(4) AND RESULTED AS ¿NOT DETECTED¿. ¿ ON (B)(6) 2025, THE SAME SST TUBE WAS RETESTED ON PANTHER AND RESULTED AS <30 DETECTED IN PANTHER WORKLIST: (B)(4). CUSTOMER ALSO TESTED A PPT SAMPLE FROM THE SAME PATIENT IN THIS WORKLIST AND THIS SAMPLE RESULTED AS 182 COPIES/ML. THE PPT TUBE WAS ALSO TESTED ON A ROCHE INSTRUMENT AND CUSTOMER STATED THIS RESULTED AS 567 COPIES/ML. THE CUSTOMER STATED THAT ALL HIV RESULTS ARE SUBJECT TO THEIR REVIEW PROCESS BEFORE DETERMINING WHICH RESULT TO REPORT. HOWEVER, THE CUSTOMER DID NOT KNOW WHICH RESULT(S) WERE REPORTED FOR SAMPLE ID (B)(6) AND IS UNABLE TO VERIFY THIS INFORMATION. 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 22366145 ↗
• InjuryJun 25, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, CUSTOMER REPORTED TO HOLOGIC THAT THEY WERE QUESTIONING A POSITIVE RESULT USING THE APTIMA HIV-1 QUANT DX ASSAY (ML 895102), ON PANTHER INSTRUMENT SERIAL NUMBER (B)(6). THE PATIENT, A PREGNANT WOMAN, SAMPLE ID: (B)(6), WAS TESTED AT DELIVERY AND PRODUCED AN HIV-1 ¿DETECTED¿ RESULT IN WORKLIST (B)(4). THE CLINICIAN NOTED THAT THE SAMPLE WAS RETESTED AS THEY ROUTINELY REQUEST RETESTING FOR SUCH CASES WHICH PRODUCED AN HIV-1 ¿NOT DETECTED¿ RESULT. ON (B)(6) 2025, THE CUSTOMER REPORTED TO HOLOGIC THAT, AS IT CONCERNED A PREGNANT WOMAN AND THE POSITIVE RESULT WOULD HAVE POTENTIALLY ALTERED THE TREATMENT OF THE MOTHER AND DELIVERY. ON JUNE 12, 2025, HOLOGIC BECAME AWARE THAT THE PATIENT RESULTS HAD BEEN REPORTED OUT. ON (B)(6) 2025, IT WAS CONFIRMED THAT THE RESULTS COULD POTENTIALLY IMPACT THE POST-EXPOSURE PROPHYLAXIS (PEP) MANAGEMENT OF A NEONATE. ON (B)(6) 2025, THE CLINICIAN NOTED THAT THE BABY WAS DUE TO RECEIVE PEP AS THE MOTHER WAS KNOWN TO BE HIV POSITIVE, AND A DETECTABLE VIRAL LOAD AT BIRTH IMPACTS DURATION AND TYPE OF PEP. THE CLINICIAN WAS NOT AWARE WHETHER THE NEONATE EXPERIENCED ANY ADVERSE SIDE EFFECTS FROM THE PEP ADMINISTRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331483 ↗
• InjuryMar 3, 2025False Positive Result; False Positive Result

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC QUESTIONABLE APTIMA HIV POSITIVE RESULTS USING APTIMA HIV-1 QUANT DX ASSAY (ML 894003), WORKLIST (B)(4), ON PANTHER INSTRUMENT SERIAL NUMBER (B)(6). CUSTOMER NOTED THAT THE PATIENT CONTESTED THE INITIAL HIV POSITIVE RESULT WHICH PROMPTED THEM TO REVIEW AMPLIFICATION CURVES AND INITIATE TESTING ON A COMPETITOR PLATFORM. CUSTOMER RETESTED THE SAME SAMPLE ON A COMPETITOR PLATFORM (GENEXPERT) AND EDTA AND SERUM SAMPLE TYPES BOTH TESTED NEGATIVE FOR HIV ON THE GENEXPERT PLATFORM. CUSTOMER REPORTED THE MALE PATIENT IS ON HIV ANTIRETROVIRAL THERAPY (ART) AND HAS TESTED HIV NEGATIVE SINCE 2015. RESULT WAS REPORTED TO HAVE BEEN AMENDED TO HIV NEGATIVE UPON TESTING ON COMPETITOR PLATFORM. PATIENT TREATMENT WAS NOT ALTERED AS A RESULT OF REPORTED RESULT. HOLOGIC WAS NOT MADE AWARE OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21510644 ↗
• InjuryJan 31, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON JANUARY 16TH, 2025, CUSTOMER REPORTED TO HOLOGIC THAT THEY WERE QUESTIONING A POSITIVE RESULT USING THE APTIMA HIV-1 QUANT DX ASSAY (ML 904418), WORKLIST WL (B)(4), ON PANTHER INSTRUMENT SERIAL NUMBER (B)(6). CUSTOMER NOTED THE POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN. PHYSICIAN DID NOT ADMINISTER TREATMENT OR MEDICATION AND QUESTIONED THE RESULT DUE TO THE PATIENT BEING ON MEDICATION TO KEEP THEIR VIRAL LOAD LOW. CUSTOMER RETESTED THE INITIALLY POSITIVE SAMPLE AND OBTAINED A NEGATIVE RESULT. CUSTOMER AMENDED THE RESULT TO NEGATIVE. HOLOGIC WAS NOT MADE AWARE OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289018 ↗
• MalfunctionDec 13, 2024Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2024, CUSTOMER REPORTED TO HOLOGIC THAT THEY WERE QUESTIONING A POSITIVE RESULT USING THE APTIMA HIV-1 QUANT DX ASSAY (ML 897723), WORKLIST: (B)(4), ON PANTHER INSTRUMENT SERIAL NUMBER: (B)(6). CUSTOMER NOTED THE POSITIVE RESULT WAS REPORTED OUT TO THE PHYSICIAN. THE PHYSICIAN SENT IN A RECOLLECTED SAMPLE FROM THE SAME PATIENT AND IT RETURNED A ¿NOT DETECTED¿ RESULT. THE INITIAL SAMPLE WAS NOT RETESTED. CUSTOMER NOTED THE PATIENT WAS ON A PRE-EXPOSURE PROPHYLAXIS (PREP) MEDICATION REGIMEN SINCE ON (B)(6) 2024 AND NO CHANGE IN TREATMENT WAS REPORTED TO HOLOGIC IN ASSOCIATION WITH THIS ISSUE. HOLOGIC WAS NOT MADE AWARE OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926931 ↗