Aptima® KIT, BX 1 (REF) M GEN, 100T, AS, IVDRecalls & reported problems
Hologic Ltd. · Aptima® Mycoplasma genitalium Assay, 100 test, box 1 of 2 (2°C to 8°C box). · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15420045509146), received between Jun 5, 2026 and Jun 5, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Imprecise or Erratic Results” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Imprecise or Erratic Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2026Imprecise or Erratic Results
ON (B)(6) 2026, CUSTOMER REPORTED RECEIVING DISCREPANT RESULTS WHILE USING THE APTIMA MYCOPLASMA GENITALIUM ASSAY (ML 920257) ON A PATIENT SAMPLE THAT WAS PART OF THEIR BI-ANNUAL INSTRUMENT COMPARISON STUDY. ON (B)(6) 2026, CUSTOMER TESTED SAMPLES ON THE PANTHER INSTRUMENT SN (B)(6) WITH WORKLIST (WL) ID (B)(4) AND RECEIVED A NEGATIVE RESULT FOR SAMPLE ID (B)(6). ON (B)(6) 2026, CUSTOMER TESTED SAMPLES ON THE PANTHER INSTRUMENT SN (B)(6) WITH WL ID (B)() AND RECEIVED A POSITIVE RESULT FOR SAMPLE ID (B)(6). ON (B)(6) 2026 CUSTOMER RETESTED SAMPLES ID (B)(6) ON A DIFFERENT PANTHER INSTRUMENT SN (B)(6) WITH WL ID (B)(4). A POSITIVE RESULT WAS RECEIVED FOR SAMPLE ID (B)(6) AND A NEGATIVE RESULT WAS RECEIVED FOR SAMPLE ID (B)(6). ON (B)(6) 2026, CUSTOMER RETESTED BOTH SAMPLES ONE MORE TIME ON THE PANTHER INSTRUMENT SN (B)(6) WITH WL ID (B)(4) AND RECEIVED THE SAME RESULTS, POSITIVE FOR SAMPLE ID (B)(6) AND NEGATIVE FOR SAMPLE ID (B)(6).CUSTOMER NOTED THAT THERE WAS A POSSIBILITY THAT THE SAMPLE IDS WERE SWAPPED DURING THE SECOND AND THIRD RETESTS. CUSTOMER DID NOT PROVIDE ANY INFORMATION ON THE PATIENT OR PATIENT TREATMENT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES R
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25411000 ↗
Other Mycoplasma Genitalium Nucleic Acid Detection System devices
- Alinity m 09N17-095Abbott Molecular Inc. · Nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections1 recall1 report
- binx io V1 (CT/NG)Binx Health Limited · Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections1 recall1 report
- Aptima Combo 2® KIT,APTIMACOMBO2,250T,REF,CEIVD-UPDATEDHologic, Inc. · Nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections6 reports
- APTIMA AC2, ROOM TEMP, 250T, READY MADEHologic, Inc. · Nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections4 reports
- BD COR CTGCTV2 US 445435Becton, Dickinson And Company · Nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections4 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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