Aptima Combo 2® KIT APTIMA COMBO 2 TIGRIS-REF (IVD)-CERecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 15420045505711), received between Mar 21, 2019 and Jul 21, 2026 — classified as 38 injuries, 1 malfunction.

The most frequently reported specific device problem is “Imprecise or Erratic Results” (14 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryJul 30, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED A DISCREPANT RESULT USING APTIMA COMBO 2 ASSAY (AC2) WHEN TESTING A SAMPLE ON PANTHER INSTRUMENTS SERIAL NUMBER (B)(6). ON (B)(6) 2025, SAMPLE ID# (B)(6) WAS TESTED ON AC2 WL011016-20250712-15 USING MASTER LOT 919672 ON PANTHER INSTRUMENT AND THE SAMPLE RESULTED CT EQUIVOCAL & GC POSITIVE. THE NEXT DAY THE CUSTOMER RETESTED THE SAME SAMPLE (DUE TO OBTAINING A CT EQUIVOCAL RESULT) ON AC2 WL-003633-20250713-15 USING MASTER LOT 919672 ON PANTHER 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. 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 22668302 ↗
• InjuryJul 25, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED DISCREPANT RESULTS USING APTIMA COMBO 2 ASSAY (AC2) WHEN TESTING A SAMPLE ON TWO DIFFERENT PANTHER INSTRUMENTS. ON (B)(6) 2025, SAMPLE ID# (B)(6) WAS TESTED ON (B)(4) USING AC2 MASTER LOT 905910 ON PANTHER INSTRUMENT SERIAL NUMBER (B)(6) AND THE SAMPLE RESULTED CT NEGATIVE & GC NEGATIVE. ON THE SAME DAY, THE CUSTOMER ACCIDENTALLY RETESTED THE SAMPLE ON (B)(4) USING AC2 MASTER LOT 905910 ON PANTHER INSTRUMENT SERIAL NUMBER (B)(6) AND IT RESULTED CT POSITIVE AND GC NEGATIVE. CUSTOMER NOTED THE CT NEGATIVE RESULT WAS AUTOMATICALLY REPORTED TO THE PHYSICIAN/PATIENT. CUSTOMER AMENDED THE CT NEGATIVE RESULT TO POSITIVE. 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 22613141 ↗
• InjuryJul 23, 2025Off-Label Use; Off-Label Use

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED DISCREPANT RESULTS FOR TWO SAMPLE IDS (SIDS) (B)(6) WHILE USING THE APTIMA COMBO 2 ASSAY MASTER LOT 917189. ON (B)(6) 2025, CUSTOMER ORIGINALLY RAN SID (B)(6) ON THE PANTHER PLUS INSTRUMENT SN (B)(6) ON WORKLIST (WL) (B)(4), WHICH RESULTED IN CT POSITIVE AND GC POSITIVE. THE SAME SAMPLE WAS LATER RERUN ON THE PANTHER PLUS INSTRUMENT SN (B)(6) ON (B)(6) 2025, ON WL (B)(4) AND RESULTED CT NEGATIVE AND GC NEGATIVE. LIKEWISE, ON (B)(6) 2025, CUSTOMER ORIGINALLY RAN SID (B)(6) ON WL (B)(4), WHICH PRODUCED A DUAL CT/GC POSITIVE RESULT. THE SAME SAMPLE WAS RERUN ON THE PANTHER PLUS INSTRUMENT SN (B)(6) ON (B)(6) 2025, ON WL (B)(4) AND PRODUCED A DUAL CT/GC NEGATIVE RESULT. PER CUSTOMER LAB POLICY, THE SAMPLE IS RETESTED IF THERE IS A DUAL CT/GC POSITIVE RESULT. CUSTOMER CONFIRMED THE DUAL CT/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 22579957 ↗
• InjuryJul 17, 2025Off-Label Use; Off-Label Use

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED DISCREPANT RESULTS USING THE APTIMA COMBO 2 ASSAY (AC2) MASTER LOT 913491 ON THE PANTHER PLUS INSTRUMENT (SERIAL NUMBER: (B)(6). ON (B)(6) 2025, SAMPLE ID (B)(6) WAS INITIALLY RUN ON WORKLIST (B)(4) AND RESULTED CT POSITIVE AND GC POSITIVE. THE SAME SAMPLE ID WAS RETESTED THE NEXT DAY UNDER WORKLIST (B)(4) AND RESULTED CT NEGATIVE AND GC NEGATIVE. CUSTOMER NOTED THEY WERE HOLDING RESULTS UNTIL A LOG REVIEW WAS PERFORMED. PER CUSTOMER LAB POLICY, THE SAMPLE IS RETESTED IF THERE IS A DUAL POSITIVE RESULT. CUSTOMER DID NOT CONFIRM IF THE DUAL POSITIVE OR THE 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 22535784 ↗
• InjuryJul 1, 2025Off-Label Use; Off-Label Use

  ON JUNE 6, 2025, A CUSTOMER REPORTED TO HOLOGIC THAT THEY WERE QUESTIONING RESULTS OF SAMPLE ID (B)(6) USING THE APTIMA COMBO 2 ASSAY (AC2) MASTER LOT 917920. ON (B)(6) 2025, THE CUSTOMER RECEIVED A DUAL POSITIVE RESULT (CT POSITIVE / GC POSITIVE) ON PANTHER SERIAL NUMBER (B)(6) UNDER WORKLIST (B)(4). THE SAMPLE WAS RETESTED ON (B)(6) 2025 AND HAD A DUAL NEGATIVE RESULT (CT NEGATIVE / GC NEGATIVE) ON PANTHER SERIAL NUMBER (B)(6) UNDER WORKLIST (B)(4). CUSTOMER REPORTED THE SAME SAMPLE TUBE WAS TESTED BOTH TIMES AND THE DUAL NEGATIVE RESULT (CT NEGATIVE / GC NEGATIVE) WAS REPORTED OUT. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373360 ↗
• InjuryJun 20, 2025Off-Label Use; Off-Label Use

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS USING APTIMA COMBO 2 ASSAY (AC2) ON PANTHER PLUS INSTRUMENT. ON (B)(6) 2025, SAMPLE ID # (B)(6) WAS INITIALLY TESTED IN AC2 WL-010146-20250614-14 USING AC2 MASTER LOT 917189 ON PANTHER PLUS INSTRUMENT SN (B)(6) AND RESULTED CT POSITIVE & GC POSITIVE. THE SAME SAMPLE WAS RETESTED ON(B)(6) 2025 IN AC2 WL-010823-20250616-19 USING AC2 MASTER LOT 917920 ON PANTHER PLUS INSTRUMENT SN (B)(6) AND RESULTED CT NEGATIVE & GC NEGATIVE. CUSTOMER REPORTED THE RETESTED CT NEGATIVE & GC NEGATIVE RESULT TO THE PHYSICIAN/PATIENT. PER APTIMA COMBO 2 ASSAY PACKAGE INSERT ¿THE FIRST VALID RESULT FOR EACH ANALYTE IS THE RESULT THAT SHOULD BE REPORTED¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302360 ↗
• InjuryJun 20, 2025Off-Label Use; Off-Label Use

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED DISCREPANT RESULTS USING APTIMA COMBO 2 ASSAY (AC2) MASTER LOT 917189 ON THEIR PANTHER INSTRUMENTS. SAMPLE ID (B)(6) INITIALLY RESULTED DUAL POSITIVE (CT POSITIVE, GC POSITIVE) ON PANTHER PLUS INSTRUMENT (SERIAL NUMBER (B)(6) UNDER WORKLIST (B)(6). THE SAME SPECIMEN WAS RETESTED AND RESULTED DUAL NEGATIVE (CT NEGATIVE, GC NEGATIVE) ON WORKLIST (B)(6) ON PANTHER INSTRUMENT (SERIAL NUMBER (B)(6). THE SPECIMEN WAS RETESTED AGAIN ON A DIFFERENT PANTHER INSTRUMENT (SERIAL NUMBER (B)(6) AND RESULTED DUAL NEGATIVE (CT NEGATIVE, GC NEGATIVE) ON WL (B)(6). CUSTOMER NOTED THAT PER LAB POLICY, THE DUAL POSITIVE RESULT WAS NOT REPORTED OUT, AND THE DUAL NEGATIVE RESULT WILL BE 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 22299397 ↗
• InjuryJun 17, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED DISCREPANT RESULTS USING APTIMA COMBO 2 ASSAY (AC2) MASTER LOT 915709 ON THE PANTHER PLUS INSTRUMENT (SERIAL NUMBER (B)(6). SAMPLE ID (B)(6) INITIALLY RESULTED CT POSITIVE AND GC EQUIVOCAL UNDER (B)(6). THE SAME SAMPLE WAS RETESTED AND RESULTED CT NEGATIVE AND GC NEGATIVE ON (B)(6). CUSTOMER CONFIRMED THAT THE DUAL NEGATIVE RESULT (CT NEGATIVE / GC NEGATIVE) 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 22240977 ↗
• InjuryMay 30, 2025Off-Label Use; Off-Label Use

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS USING APTIMA COMBO 2 ASSAY (AC2) MASTER LOT 915709 ON PANTHER PLUS INSTRUMENT. SAMPLE ID# (B)(6) INITIALLY RESULTED CT POSITIVE & GC POSITIVE ON AC2 (B)(4) ON PANTHER PLUS INSTRUMENT SN (B)(6). THE SAME SAMPLE WAS RETESTED AND RESULTED CT NEGATIVE & GC NEGATIVE ON AC2 (B)(4) ON PANTHER PLUS INSTRUMENT SN (B)(6). CUSTOMER REPORTED THE RETESTED CT NEGATIVE & GC NEGATIVE RESULT TO THE PATIENT. PER APTIMA COMBO 2 ASSAY PACKAGE INSERT ¿THE FIRST VALID RESULT FOR EACH ANALYTE IS THE RESULT THAT SHOULD BE REPORTED¿. CUSTOMER WAS INFORMED THAT NOT REPORTING OUT THE FIRST VALID RESULT IS CONSIDERED OFF-LABEL. CUSTOMER NOTED THAT THEY ARE AWARE BUT PER THEIR LAB SOP, ALL DUAL POSITIVE SAMPLES WITH RELATIVE LIGHT VALUES (RLUS) <1900 ARE TO BE REPEATED AND IF THE RETEST IS NEGATIVE, THEY REPORT OUT THE NEGATIVE RESULT. 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 22116412 ↗
• InjuryMay 8, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC HIGH LEVELS OF POSITIVE RESULTS WHILE USING THE APTIMA COMBO 2 ASSAY (LOT NUMBER: 909770) ON THE PANTHER INSTRUMENT (SERIAL NUMBER: (B)(6)). ON (B)(6) 2025, SAMPLE ID (B)(6) INITIALLY TESTED CT NEGATIVE/GC POSITIVE IN WORKLIST (B)(4). ON (B)(6) 2025, THE SAME SAMPLE WAS RETESTED ON WORKLIST (B)(4) AND RESULTED CT NEGATIVE/GC NEGATIVE. CUSTOMER CONFIRMED THE CT NEGATIVE/GC NEGATIVE RETEST RESULT WAS REPORTED OUT. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21987536 ↗
• InjuryMay 2, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC A POTENTIAL FALSE NEGATIVE NEISSERIA GONORRHOEAE (GC) RESULT WHILE USING THE APTIMA COMBO 2 ASSAY (LOT NUMBER: 905100) ON THE PANTHER INSTRUMENT (B)(6). (B)(6) INITIALLY TESTED CT NEGATIVE AND GC POSITIVE, BUT GENERATED CT NEGATIVE AND GC NEGATIVE RESULTS UPON RETEST IN THE SAME AC2 (B)(4). CUSTOMER CONFIRMED THE RETEST GC NEGATIVE RESULT WAS REPORTED OUT TO THE CLINICIAN. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952202 ↗
• InjuryJan 14, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  FOLLOW-UP REPORT. SEE SECTION H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21151355 ↗
• InjuryDec 5, 2024Imprecise or Erratic Results; Imprecise or Erratic Results

  ON NOVEMBER 11, 2024, A CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED DISCREPANT RESULTS USING APTIMA COMBO 2 (AC2) ASSAY MASTER LOT 902420 ON THE PANTHER INSTRUMENT. SAMPLE ID (B)(6) INITIALLY TESTED CT NEGATIVE / GC NEGATIVE. HOWEVER, THE CUSTOMER ACCIDENTALLY RETESTED THE SAME SAMPLE TUBE USING A DIFFERENT PANTHER INSTRUMENT, AND THE SAMPLE RESULTED CT POSITIVE / GC NEGATIVE. THE INITIAL CT NEGATIVE / GC NEGATIVE RESULT WAS REPORTED. HOLOGIC IS NOT AWARE IF THE RESULT WAS AMENDED OR IF THE PATIENT RECEIVED TREATMENT. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20855259 ↗
• MalfunctionNov 5, 2024Imprecise or Erratic Results; Imprecise or Erratic Results

  ON OCTOBER 10TH 2024, A CUSTOMER REPORTED THREE SUSPECTED FALSE POSITIVE GC RESULTS USING THE APTIMA COMBO 2 ASSAY. SAMPLES WERE TESTED IN WORKLIST: 002536-20240916-45 ((B)(6)) & 002536-20241003-12 (24M113251 & 24M113075), USING ASSAY LOTS 899831 AND 901175 ON PANTHER INSTRUMENT SERIAL NUMBER (B)(6) AND TESTED POSITIVE FOR GC. CUSTOMER NOTED THE RESULTS WERE QUESTIONED BY THE PHYSICIAN: TWO SAMPLES CAME FROM PREGNANT PATIENTS AND THE OTHER SAMPLE CAME FROM A PATIENT WHOSE SPOUSE TESTED NEGATIVE FOR GC. ONE OF THE PATIENTS (SAMPLE ID ((B)(6)) RECEIVED TREATMENT BASED ON THE POSITIVE GC RESULT AND NO ADDITIONAL TESTING WAS PERFORMED. NO NEGATIVE IMPACTS FROM THE TREATMENT WERE REPORTED. SAMPLES FROM THE OTHER TWO PATIENTS WERE RECOLLECTED RESULTED GC NEGATIVE. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20615478 ↗
• InjuryOct 1, 2024Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2024, A CUSTOMER REPORTED TO HOLOGIC THAT THEY OBTAINED A DISCREPANT GC RESULT USING THE APTIMA COMBO 2 ASSAY, MASTER LOT 899831. THE SPECIMEN WAS INITIALLY TESTED ON (B)(6) 2024 AND RESULTED GC POSITIVE. THE SAMPLE WAS RETESTED ON (B)(6) 2024, AND AGAIN ON (B)(6) 2024, AND RESULTED AS GC NEGATIVE BOTH TIMES. THE RESULT WAS AMENDED BUT THE CUSTOMER CONFIRMED THAT PATIENT TREATMENT WAS PROVIDED BASED ON THE INITIAL POSITIVE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344844 ↗
• InjuryJul 21, 2023Imprecise or Erratic Results; Imprecise or Erratic Results

  THE CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED ONE DISCREPANT AC2 RESULT USING ASSAY LOT 544905 RUN ON PANTHER INSTRUMENT SN (B)(6). THE SAMPLE IN QUESTION INITIALLY RESULTED CT-NEGATIVE AND GC-POSITIVE (329 RLUS) ON (B)(6) 2023. THE CUSTOMER RETESTED THIS SAMPLE ON (B)(6) 2023 AS PART OF THE LAB'S QA PROCESS OF RETESTING POSITIVE AC2 SAMPLES THAT HAVE AN RLU VALUE LESS THAN 1000. THE CUSTOMER IS AWARE THE AC2 PACKAGE INSERT (PI) INSTRUCTS OPERATORS TO REPORT THE FIRST VALID RESULT FOR EACH ANALYTE. THE CUSTOMER RETESTED THE SAME SAMPLE TUBE AND CONFIRMED THE SAMPLE WAS STORED ACCORDING TO THE AC2 PI IN BETWEEN TESTS. UPON RETEST, THE SAMPLE RESULTED CT-POSITIVE AND GC-POSITIVE (2365 RLUS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375340 ↗
• InjuryOct 20, 2021False Negative Result; False Negative Result

  INITIAL/FINAL. ON (B)(6) 2021 A CUSTOMER FROM (B)(6), REPORTED RECEIVING (B)(6) RESULTS WHEN TESTING A SAMPLE WITH THE APTIMA COMBO 2 (AC2) ASSAY AND THE APTIMA CHLAMYDIA TRACHOMATIS (ACT) ASSAY. THE CUSTOMER INITIALLY TESTED THE PATIENT URINE COLLECTED IN AN APTIMA URINE SPECIMEN COLLECTION KIT ON (B)(6) 2021 IN THEIR PANTHER FUSION INSTRUMENT WITH THE AC2 ASSAY AND OBTAINED A (B)(6) RESULT. THE SAMPLE WAS THEN FROZEN FOR STORAGE, THEN THAWED ON (B)(6) 2021 AND USED AS A SAMPLE FOR THEIR VALIDATING THEIR LEADER HC+ MANUAL PLATFORM, WHERE THEY TESTED WITH THE ACT ASSAY AND OBTAINED A (B)(6) RESULT. THE SAMPLE WAS RETESTED ON EACH PLATFORM/ASSAY AND THE CUSTOMER CONFIRMED THEIR INITIAL RESULTS. PER HOLOGIC'S REQUEST, THE CUSTOMER SENT THE SAMPLE TO HOLOGIC FOR ANALYSIS. FOLLOWING THE IN-HOUSE CONFIRMATORY TESTING, THE RNA FROM THE SAMPLE WAS EXTRACTED AND SEQUENCED TO COMPARE TO KNOWN CT VARIANTS. ON (B)(6) 2021, SEQUENCING FOUND THAT THE SAMPLE MATCHES THE SEQUENCE OF THE PREVIOUSLY IDENTIFIED (B)(6). OF NOTE, THIS SAMPLE IS THE FIRST INSTANCE THE (B)(6) IDENTIFIED IN THE US. PER RISK ASSESSMENT, THERE IS NO INDICATION THAT THE PRODUCT IS NOT PERFORMING AS INTENDED OR IS MALFUNCTIO

  Patient problems: Sexually Transmitted Infection

  MAUDE report 12666905 ↗
• InjuryJul 16, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  INITIAL AND FINAL REPORT. ON DECEMBER 14, 2020, HOLOGIC SCIENTIFIC AFFAIRS WAS NOTIFIED OF TWO CT VARIANTS THAT WERE FOUND AS PART OF A RESEARCH STUDY THAT CDC WAS PERFORMING IN COLLABORATION WITH LABCORP AND FACILITATED BY HOLOGIC. FOR THIS STUDY, THE CDC RECEIVED A SELECTED SET OF SAMPLES FROM LABCORP - NAMELY, N=50 SPECIMENS (TESTED WITH THE AC2 ASSAY BETWEEN DECEMBER 2019 - FEBRUARY 2020) WITH CT-NEGATIVE OR CT-EQUIVOCAL RESULTS (RLU SIGNAL (X 1,000) GREATER THAN/EQUAL TO 15-99). ONE PURPOSE OF THE CDC STUDY WAS TO EXPLORE THE PRESENCE OF CT 23S VARIANTS IN THE UNITED STATES. THE CDC IDENTIFIED TWO CT VARIANTS IN THIS STUDY. ONE OF THE SEQUENCES CARRIED THE G1526A MUTATION, WHICH WAS A PREVIOUSLY IDENTIFIED CT VARIANT. NOTE: THIS VARIANT WAS PREVIOUSLY REPORTED TO FDA IN JUNE 2019 AND MARCH 2020. THE OTHER SEQUENCE CARRIED A A1518G MUTATION, WHICH IS A NOVEL CT VARIANT. A1518G IS A NEW VARIANT NOT IDENTIFIED IN ANY SAMPLE BEFORE. THIS MDR IS TO REPORT THE 2ND VARIANT. THERE IS NO INDICATION THAT THE PRODUCT IS NOT PERFORMING AS INTENDED OR IS MALFUNCTIONING. THE GUIDELINES FOR MEDICAL DEVICE REPORTING (21 CFR PART 803 MDR) WERE REVIEWED FROM THE FDA WEBSITE. BEGINNING IN 2019,

  Patient problems: Viral Infection

  MAUDE report 12184934 ↗