Aptima Combo 2® KIT,APTIMACOMBO2,250T,REF,CEIVD-UPDATEDRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15420045512832), received between Nov 19, 2025 and Sep 8, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Imprecise or Erratic Results” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026False Negative Result

  On (b)(6) 2026 a customer in Spain reported to Hologic that discrepant results were generated using the Aptima Combo 2 (AC2) assay (Master Lot: 930679) with Panther instruments SN# (b)(6). On (b)(6) 2026, sample IDs (b)(6) were tested in Panther Worklist ID (b)(4) and each generated a Chlamydia Trachomatis (CT) negative result. The same samples (IDs (b)(6)) were retested on another Panther instrument on (b)(6) 2026, under Worklist ID (b)(4), and each generated a Chlamydia Trachomatis (CT) positive result. No information regarding patient treatment is available at this time. Hologic has not been informed of any adverse patient outcome related to this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50671724 ↗
• InjuryJun 3, 2026Imprecise or Erratic Results

  ON (B)(6) 2026, CUSTOMER REPORTED TO HOLOGIC INCONSISTENT SAMPLE RESULTS WHILE PERFORMING VALIDATION TESTING WHILE USING THE APTIMA COMBO 2 (AC2) ASSAY ON THEIR PANTHER FUSION PLUS INSTRUMENTS. CUSTOMER CONFIRMED THAT THE INITIAL TEST RESULTS WERE REPORTED OUT. CUSTOMER PROVIDED LOGS. ON (B)(6) 2026, SAMPLE ID (SID) (B)(6) WAS INITIALLY TESTED ON CT/GC WORKLIST (B)(4) (ML 926168) ON PANTHER INSTRUMENT (SN (B)(6) AND RESULTED CT POSITIVE/GC NEGATIVE. ON (B)(6) 2026, CUSTOMER RETESTED THE SAME SAMPLE (SID) (B)(6) ON CT/GC WORKLIST (B)(4) (ML 928004) ON A DIFFERENT PANTHER INSTRUMENT (SN (B)(6), AND THE VALIDATION TEST RESULTED CT POSITIVE/GC POSITIVE. CUSTOMER DID NOT PROVIDE ANY INFORMATION ON THE PATIENT OR PATIENT TREATMENT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE. INSTRUMENT WAS OPERATIONAL, AND NO FURTHER ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25384549 ↗
• InjuryMay 27, 2026Imprecise or Erratic Results

  ON 8 MAY 2026, A CUSTOMER IN FINLAND REPORTED TO HOLOGIC THAT DISCREPANT RESULT WAS GENERATED WHILST USING THE AC2 ASSAY WITH PANTHER INSTRUMENT (SERIAL NUMBER: (B)(6). ON (B)(6) 2026, SAMPLE WAS TESTED IN PANTHER AND GENERATED A CHLAMYDIA TRACHOMATIS (CT) POSITIVE/NEISSERIA GONORRHOEA (GC) NEGATIVE RESULT. THE SAME SAMPLE WAS RETESTED ON (B)(6) ON THE PANTHER INSTRUMENT AND GENERATED A CHLAMYDIA TRACHOMATIS (CT) POSITIVE/NEISSERIA GONORRHOEAE (GC) POSITIVE RESULT. ON (B)(6) 2026, SAMPLE WAS TESTED IN PANTHER AND GENERATED A CHLAMYDIA TRACHOMATIS (CT) NEGATIVE/NEISSERIA GONORRHOEA (GC) POSITIVE RESULT. THE SAME SAMPLE WAS RETESTED ON 22 APRIL ON THE PANTHER INSTRUMENT AND GENERATED A CHLAMYDIA TRACHOMATIS (CT) POSITIVE/NEISSERIA GONORRHOEAE (GC) POSITIVE RESULT. MAS REQUESTED LOGS. NO SYSTEM LOG FILES OR ADDITIONAL SUPPORTING DOCUMENTATION WERE PROVIDED BY THE CUSTOMER FOR REVIEW BY HOLOGIC TECHNICAL SUPPORT YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25309482 ↗
• InjuryApr 13, 2026Imprecise or Erratic Results

  ON (B)(6) 2026, CUSTOMER REPORTED RECEIVING DISCREPANT RESULTS WHILE USING THE APTIMA COMBO 2 (AC2) ASSAY (ML 924882) ON THEIR PANTHER PLUS INSTRUMENT (SN (B)(6). ON (B)(6) 2026, CUSTOMER INITIALLY TESTED 15 SAMPLES ON AC2 WORKLIST (WL) (B)(6) AND RECEIVED A CT POSITIVE/GC NEGATIVE RESULT ON SEVEN SAMPLES, AND CT NEGATIVE/GC NEGATIVE RESULTS ON THE OTHER EIGHT SAMPLES. CUSTOMER WAS CONCERNED ABOUT A CLUSTER OF SIX CT POSITIVE/GC NEGATIVE SAMPLES AND RE-TESTED ALL 15 SAMPLES USING THE SAME AC2 ASSAY KIT. THE REPEAT(B)(6) CONTAINED DISCREPANT RESULTS ON FIVE SAMPLES: SID (B)(6) RESULTED CT NEGATIVE/GC NEGATIVE (ORIGINALLY CT POSITIVE/GC NEGATIVE) AND SID (B)(6) RESULTED CT POSITIVE/GC NEGATIVE (ORIGINALLY CT NEGATIVE/GC NEGATIVE). CUSTOMER REPORTED THE CT NEGATIVE/GC NEGATIVE RESULTS FROM THE REPEAT (B)(6) CUSTOMER DID NOT PROVIDE ANY INFORMATION ON THE PATIENT OR PATIENT TREATMENT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24860717 ↗
• InjuryDec 16, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER IN FRANCE REPORTED TO HOLOGIC THAT A DISCREPANT RESULT WAS GENERATED WHILST USING THE AC2 ASSAY (MASTER LOT: 919348) WITH PANTHER INSTRUMENT (SERIAL NUMBER: (B)(6)). THE INCIDENT WAS RECORDED UNDER HOLOGIC REFERENCE NUMBER (B)(4). ON (B)(6) 2025, THE SAMPLE ID (B)(6) WAS TESTED IN PANTHER WORKLIST ID (B)(4) AND GENERATED A CHLAMYDIA TRACHOMATIS (CT) NEGATIVE /NEISSERIA GONORRHOEA (GC) NEGATIVE RESULT. THE SAME SAMPLE (ID (B)(6)) WAS RETESTED ON (B)(6) 2025 ON THE SAME PANTHER INSTRUMENT (WORKLIST ID (B)(4)) AND GENERATED A CHLAMYDIA TRACHOMATIS (CT) POSITIVE/NEISSERIA GONORRHOEAE (GC) NEGATIVE RESULT. ON (B)(6) 2025, THE SAME SAMPLE (ID (B)(6)) WAS RETESTED AGAIN, THIS TIME ON ANOTHER PANTHER INSTRUMENT (WORKLIST ID (B)(4)) AND GENERATED A CHLAMYDIA TRACHOMATIS (CT) POSITIVE/NEISSERIA GONORRHOEAE (GC) NEGATIVE RESULT. NO INFORMATION REGARDING PATIENT TREATMENT IS AVAILABLE AT THIS TIME. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOME RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816699 ↗
• InjuryNov 19, 2025False Negative Result; Imprecise or Erratic Results; False Negative Result; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER IN THE NETHERLANDS REPORTED A DISCREPANT APTIMA COMBO 2 RESULT, USING MASTER LOT: 912861 ON THE PANTHER INSTRUMENT WITH SN#: (B)(6). CUSTOMER TESTED SAMPLE ID: (B)(6) ON (B)(6) 2025 WHERE IT RESULTED CHLAMYDIA TRACHOMATIS (CT) NEGATIVE AND NEISSERIA GONORRHOEAE (GC) NEGATIVE. THE NEGATIVE RESULTS WERE REPORTED OUT TO THE PHYSICIAN. ON (B)(6) 2025, THE SAME SAMPLE WAS RETESTED BY THE LABORATORY, WHERE IT RESULTED CT POSITIVE AND GC NEGATIVE. CUSTOMER PERFORMED CONFIRMATORY TESTING WITH THE ALLPLEX STI ESSENTIAL ASSAY WITH THE SEEGENE WORKFLOW, WHERE THE SAMPLE TESTED CT POSITIVE. THE LABORATORY ADDITIONALLY PERFORMED A TEST FOR LYMPHOGRANULOMA VENEREUM (AN INFECTION CAUSED BY CHLAMYDIA TRACHOMATIS) USING THE ALLPLEX GENITAL ULCER ASSAY WHERE THE RESULT WAS POSITIVE. CUSTOMER SUBSEQUENTLY AMENDED THE RESULT TO CT POSITIVE. NO REPEAT SAMPLING WAS REPORTED TO HOLOGIC FOR THE IMPACTED PATIENT. THE PATIENT WAS TREATED WITH ANTIBIOTICS PER THE DUTCH ASSOCIATION FOR DERMATOLOGY AND VENEREOLOGY MULTIDISCIPLINARY GUIDELINES. IT WAS INDICATED THE SAMPLE MAY HAVE COME FROM A SEX WORKER BEING TESTED ASYMPTOMATICALLY. NO ADVERSE PATIENT OUTCOMES WERE REPORTED TO HOLOGI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597019 ↗