Aptima Combo 2Recalls & reported problems across all models

We found 4 models of Aptima Combo 2 by Hologic, Inc. in the FDA's device registry (GUDID). Together they are named in 50 adverse event reports in the FDA's MAUDE database, received between Sep 12, 2017 and Sep 8, 2026 — classified as 49 injuries, 1 malfunction.

The most frequently reported specific device problem is “Imprecise or Erratic Results” (19 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. 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

Most reported Aptima Combo 2 problems

Aptima Combo 2 models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Aptima Combo 2® KIT APTIMA COMBO 2 TIGRIS-REF (IVD)-CE

  DNA-REAGENTS, NEISSERIA
  39 reports
• Aptima Combo 2® KIT,APTIMACOMBO2,250T,REF,CEIVD-UPDATED

  Nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections
  6 reports
• Aptima Combo 2® KIT,APTIMACOMBO2,100T,REF,CEIVD-UPDATED

  DNA-REAGENTS, NEISSERIA
  3 reports
• Aptima Combo 2® KIT, BX 1 (REFRIG) AC2, 100T, AS, IVD

  DNA-REAGENTS, NEISSERIA
  2 reports

Recent Aptima Combo 2 adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryJul 21, 2026Imprecise or Erratic Results

  ON (B)(6) 2026, A CUSTOMER IN UNITED KINGDOM REPORTED TO HOLOGIC THAT A DISCREPANT RESULT WAS GENERATED WHILST USING THE AC2 ASSAY (MASTER LOT: 930679) WITH PANTHER INSTRUMENT (SERIAL NUMBER: (B)(6). THE INCIDENT WAS RECORDED UNDER HOLOGIC REFERENCE NUMBER CPT-02110133. ON (B)(6) 2026, SAMPLE ID (B)(6) WAS TESTED IN PANTHER WORKLIST ID (B)(6) AND GENERATED A CHLAMYDIA TRACHOMATIS (CT) NEGATIVE / NEISSERIA GONORRHEA (GC) NEGATIVE RESULT. THE SAME SAMPLE (ID (B)(6) WAS RETESTED ON ANOTHER PANTHER INSTRUMENT AND GENERATED A NEISSERIA GONORRHOEAE (GC) POSITIVE RESULT. LATER, THE SAMPLE WAS RETESTED AGAIN ON THE PANTHER INSTRUMENT AND GENERATED A NEISSERIA GONORRHEA (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 25895851 ↗
• 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 ↗
• InjuryMay 8, 2026Imprecise or Erratic Results

  ON APRIL 29, 2026, CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS WHILE PERFORMING A LOT-TO-LOT VERIFICATION FOR SAMPLE ID (SID): (B)(6) WHILE USING THE APTIMA COMBO 2 ASSAY ON THEIR PANTHER INSTRUMENT WITH SERIAL NUMBER (SN): (B)(6). ON (B)(6) 2026, SID: (B)(6) WAS INITIALLY TESTED ON WORKLIST (WL) (B)(4) (ML 924056) ON PANTHER INSTRUMENT (SN: (B)(6) AND RESULTED CT NEGATIVE/GC POSITIVE. ON (B)(6) 2026, CUSTOMER RETESTED SID: (B)(6) ON WORKLIST (B)(4) (ML 926168) ON PANTHER INSTRUMENT (SN: (B)(6) AND THE SAMPLE RESULTED CT POSITIVE/GC POSITIVE. ACCORDING TO THE CUSTOMER, THE FIRST VALID RESULT WAS REPORTED TO THE PATIENT. 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 25128789 ↗
• 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 ↗
• InjuryFeb 4, 2026Imprecise or Erratic Results

  ON JANUARY 6, 2026, CUSTOMER REPORTED THAT THEY RECEIVED DISCREPANT RESULTS ON NINE SAMPLES WHILE USING THE APTIMA COMBO 2 (AC2) ASSAY (ML 924882) ON THEIR PANTHER PLUS INSTRUMENT ((B)(6)). ON (B)(6) 2026, CUSTOMER INITIALLY TESTED THE NINE SAMPLES ON AC2 WORKLIST (WL) (B)(4) AND RECEIVED A CT POSITIVE/ GC POSITIVE RESULT ON SAMPLE ID (B)(6) AND CT NEGATIVE/GC NEGATIVE RESULTS ON THE OTHER EIGHT SID¿S; (B)(6). CUSTOMER SUSPECTED ENVIRONMENTAL CONTAMINATION AND RE-RAN THE SAMPLES IN QUESTION USING A NEWLY RECONSTITUTED ASSAY KIT. CUSTOMER PERFORMED A RETEST OF ALL NINE SAMPLES ON WORKLIST IDS (WL) (B)(4) AND (WL) (B)(4) AND RECEIVED A CT NEGATIVE/GC POSITIVE RESULT ON SAMPLE ID ((B)(6)) AND CT POSITIVE/GC NEGATIVE RESULTS ON SID; (B)(6). CUSTOMER REPORTED OUT THE RESULTS FROM THE INITIAL WL (B)(4). 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 24257644 ↗
• 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 ↗
• InjuryOct 30, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED DISCREPANT CHLAMYDIA TRACHOMATIS (CT) RESULTS ON THREE SAMPLES WHILE USING THE APTIMA COMBO 2 ASSAY (AC2, ML (B)(6)) ON THEIR PANTHER FUSION PLUS INSTRUMENT (SN (B)(6)). ON (B)(6) 2025, CUSTOMER TESTED THREE SAMPLE IDS (SIDS) (B)(6) ON PANTHER FUSION PLUS WORKLIST (WL) (B)(4) AND RECEIVED CT POSITIVE, CT POSITIVE, AND CT NEGATIVE RESULTS, RESPECTIVELY. CUSTOMER REPORTED OUT THESE SAMPLE RESULTS. CUSTOMER SUSPECTED POSSIBLE CONTAMINATION DUE TO HARDWARE ERRORS IN THE DAY FOLLOWING THE INITIAL TEST AND DECIDED TO RETEST THESE SAMPLES ON A DIFFERENT PANTHER INSTRUMENT (SN (B)(6)) UNDER WL (B)(4). UPON RETEST, CUSTOMER RECEIVED CT NEGATIVE, CT NEGATIVE, AND CT POSITIVE RESULTS FOR THESE SAMPLES SID (B)(6), RESPECTIVELY. CUSTOMER AMENDED THE INITIAL RESULTS WITH THE RETEST RESULTS AND REPORTED THEM OUT. CUSTOMER DID NOT HAVE ADDITIONAL PATIENT INFORMATION. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426132 ↗
• InjuryOct 17, 2025Off-Label Use; Off-Label Use

  ON (B)(6) 2025, A CUSTOMER REPORTED A DISCREPANT RESULT USING THE APTIMA COMBO 2 (AC2) ASSAY ON THEIR PANTHER INSTRUMENT. ON (B)(6) 2025, SAMPLE ID: (B)(6) RESULTED AS GC POSITIVE, CT NEGATIVE WITH MASTER LOT 922619 ON WORKLIST (B)(4). CUSTOMER REPORTED THEY HAVE MADE IT THEIR LAB POLICY TO RETEST ANY POSITIVE RESULT WITH AN RLU VALUE BELOW 1000. ON (B)(6) 2025, CUSTOMER RERAN THE SAMPLE USING THE SAME MASTER LOT ON WORKLIST (B)(4) WHERE IT RESULTED AS DOUBLE CT NEGATIVE / GC NEGATIVE. CUSTOMER RELAYED THE INITIAL POSITIVE RESULT WAS HELD BACK, BUT DUE TO HOW THEIR LIS WAS PROGRAMMED, THE NEGATIVE RESULT WAS TRANSMITTED TO THE CAREGIVER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324704 ↗
• InjuryOct 17, 2025Off-Label Use; Off-Label Use

  ON (B)(6) 2025, A CUSTOMER REPORTED A DISCREPANT RESULT USING THE APTIMA COMBO 2 (AC2) ASSAY ON THEIR PANTHER INSTRUMENT. ON (B)(6) 2025, SAMPLE ID (B)(6) RESULTED AS CT POSITIVE, GC NEGATIVE WITH MASTER LOT 915869 ON WORKLIST (B)(4). CUSTOMER REPORTED THEY HAVE MADE IT THEIR LAB POLICY TO RETEST ANY POSITIVE RESULT WITH AN RLU VALUE BELOW 1000. ON (B)(6) 2025, CUSTOMER RERAN THE SAMPLE USING MASTER LOT 922619 ON WORKLIST (B)(4) WHERE IT RESULTED AS DOUBLE CT NEGATIVE / GC NEGATIVE. CUSTOMER RELAYED THE INITIAL POSITIVE RESULT WAS HELD BACK, BUT DUE TO HOW THEIR LIS WAS PROGRAMMED, THE NEGATIVE RESULT WAS TRANSMITTED TO THE CAREGIVER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324701 ↗
• InjurySep 12, 2025Off-Label Use; Off-Label Use

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC A DISCREPANT RESULT FOR SAMPLE ID (SID) (B)(6) WHILE USING APTIMA COMBO 2 ASSAY MASTER LOT 922367 ON THEIR PANTHER INSTRUMENT. ON (B)(6) 2025, CUSTOMER INITIALLY TESTED SID (B)(6) ON THE PANTHER PLUS INSTRUMENT SN (B)(6) ON WORKLIST (WL) (B)(4) AND RECEIVED A DUAL CT POSITIVE, GC POSITIVE RESULT. PER CUSTOMER LAB POLICY, A SAMPLE IS RETESTED IF THERE IS A DUAL CT POSITIVE, GC POSITIVE RESULT. ON (B)(6) 2025, CUSTOMER RETESTED THE DUAL POSITIVE SID (B)(6) ON (B)(4) ON A DIFFERENT PANTHER INSTRUMENT SN (B)(6) AND RECEIVED A DUAL CT NEGATIVE, GC NEGATIVE RESULT. CUSTOMER CONFIRMED THE DUAL CT NEGATIVE, GC 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 23040088 ↗
• InjuryAug 19, 2025Off-Label Use; Off-Label Use

  ON (B)(6) 2025, CUSTOMER REPORTED A DISCREPANT RESULT USING APTIMA COMBO 2 (AC2) ASSAY MASTER LOT 921141 ON PANTHER PLUS INSTRUMENT. ON (B)(6) 2025, SAMPLE SID (B)(6) WAS TESTED USING AC2 (B)(4) ON PANTHER PLUS INSTRUMENT SERIAL NUMBER (B)(6) AND RETURNED A CT POSITIVE / GC POSITIVE RESULT. HOLOGIC TECHNICAL SUPPORT INFORMED THE CUSTOMER THAT PER APTIMA COMBO 2 ASSAY PACKAGE INSERT, THE FIRST VALID RESULT FOR EACH ANALYTE IS THE RESULT THAT SHOULD BE REPORTED. CUSTOMER NOTED THEY WERE AWARE, BUT PER THEIR LABORATORY PROTOCOL, THEY ARE REQUIRED TO RETEST DUAL POSITIVE SAMPLES WITH RLU < 1900. ON (B)(6) 2025, THE SAME SAMPLE SID (B)(6) WAS RETESTED USING AC2 (B)(4) ON PANTHER PLUS INSTRUMENT SERIAL NUMBER (B)(6) AND RETURNED A CT NEGATIVE / GC NEGATIVE RESULT. CUSTOMER REPORTED OUT THE CT NEGATIVE / GC NEGATIVE RESULT TO THE PHYSICIAN/PATIENT. 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 22845763 ↗
• InjuryAug 15, 2025Off-Label Use; Off-Label Use

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC A DISCREPANT RESULT USING THE APTIMA COMBO 2 ASSAY (AC2) FROM MASTER LOT 919672 ON THE PANTHER PLUS INSTRUMENT (SN: (B)(6). THE CUSTOMER INITIALLY TESTED THE SAMPLE ON (B)(6) 2025 UNDER WORKLIST (B)(4) AND RECEIVED A DUAL POSITIVE RESULT (CT POSITIVE/GC POSITIVE). THE SAME SAMPLE WAS RETESTED ON (B)(6) 2025 UNDER WORKLIST (B)(4) AND RESULTED DUAL NEGATIVE (CT NEGATIVE/GC NEGATIVE). THE CUSTOMER REPORTED OUT THE DUAL NEGATIVE RESULT (CT NEGATIVE/GC NEGATIVE). 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 22816356 ↗

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