Aptima Combo 2® KIT,APTIMACOMBO2,100T,REF,CEIVD-UPDATEDRecalls & reported problems
Hologic, Inc. · Aptima Combo 2® assay, 100 test, box 1 of 2 (2°C to 8°C box). The Aptima Combo 2® assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal disease using the Panther® system as specified. · Class 2
All models of Aptima Combo 2 (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15420045512894), received between Oct 21, 2022 and Oct 17, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Off-Label Use” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Off-Label Use2
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryOct 21, 2022No Apparent Adverse Event; No Apparent Adverse Event
CUSTOMER CONTACTED HOLOGIC ON (B)(6) 2022 QUESTIONING AC2 ASSAY RESULT FROM LOT 327730. CUSTOMER WAS RUNNING THE UPDATED APTIMA COMBO 2 ASSAY. CUSTOMER PROVIDED SAMPLES TO HOLOGIC FOR EVALUATION. HOLOGIC PERFORMED TESTING OF THE SAMPLES USING THE UPDATED APTIMA COMBO 2 ASSAY AND CONFIRMED THE POSITIVE RESULTS. THE RESULTS ARE CONSISTENT WITH A CT VARIANT, ALTHOUGH SEQUENCING HAS NOT YET BEEN PERFORMED TO CONFIRM IF THE SAMPLE ARE A CT VARIANT(S).
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15655759 ↗
Other DNA-REAGENTS, NEISSERIA devices
- BD COR™ MX 443989Becton, Dickinson And Company · DNA-REAGENTS, NEISSERIA1 recall4 reports
- Aptima Combo 2® KIT APTIMA COMBO 2 TIGRIS-REF (IVD)-CEHologic, Inc. · DNA-REAGENTS, NEISSERIA39 reports
- BD CTGCTV2 for BD MAX™ System 443904Becton, Dickinson And Company · DNA-REAGENTS, NEISSERIA35 reports
- BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA Assay 441126Becton, Dickinson And Company · DNA-REAGENTS, NEISSERIA5 reports
- BD Viper™ System 441091Becton, Dickinson And Company · DNA-REAGENTS, NEISSERIA3 reports
- Aptima Combo 2® KIT, BX 1 (REFRIG) AC2, 100T, AS, IVDHologic, Inc. · DNA-REAGENTS, NEISSERIA2 reports
- BD Viper™ System Remanufactured 442843Becton, Dickinson And Company · DNA-REAGENTS, NEISSERIA2 reports
- Aptima® APTIMA VAGINAL SWAB COLLECTION KITHologic, Inc. · DNA-REAGENTS, NEISSERIA2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page