BD ProbeTec™ Neisseria gonorrhoeae (GC) Qx Assay Gray Amp Reagent Pack 442842Recalls & reported problems
Becton, Dickinson And Company · BD ProbeTec™ Neisseria gonorrhoeae (GC) Qx Assay Gray Amp Reagent Pack · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382904428426), received between Aug 31, 2023 and Aug 31, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Positive Result” (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.
Most reported problems
Device problems
- False Positive Result1
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.
MalfunctionAug 31, 2023False Positive Result; False Positive Result
IT WAS REPORTED THAT WHILE USING BD PROBETEC¿ NEISSERIA GONORRHOEAE (GC) QX ASSAY GRAY AMP REAGENT PACK PATIENT SAMPLE TESTED POSITIVE FOR GC HOWEVER WHEN RETESTED PATIENT WAS GC NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS ONE PATIENT SAMPLE WITH A DISCREPANT GC RESULT WHILE USING CAT 442842 LOT 2348937. PER CUSTOMER, A CT/GC SPECIMEN WAS TESTED ON (B)(6) 2023 AND IT WAS POSITIVE FOR GC. PROVIDED CALLED CUSTOMER ON (B)(6) 2023 ASKING FOR SPECIMEN TO BE REPEATED AS PATIENT SHOULD NOT BE POSITIVE. PATIENT HAD TESTING DONE AT ANOTHER FACILITY AND GC RESULT WAS NEGATIVE. CUSTOMER COULD NOT PROVIDE THE NAME OF THE OTHER FACILITY OR THE INSTRUMENTATION/METHODOLOGY USED. LAST CT/GC EM WERE PERFORMED ON (B)(6) 2023. CUSTOMER ALTERNATES EVERY OTHER MONTH WITH HPV. CT/GC ONLY PERFORMED ONCE A WEEK. CUSTOMER WILL REPEAT THE SPECIMEN ON (B)(6) 2023 WITH THE REST OF THE NEW SPECIMENS AND EM. PER CUSTOMER, THE SPECIMEN HAD A VERY LOW VALUE IN THE REPORT. FOLLOW UP EMAIL SENT TO CUSTOMER REQUESTING RESULT PRINT OUT. IF YES, DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): GC RESULT WAS REPORTED AS POSITIVE. PATIENT QUESTIONED THE RESULTS AN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17663467 ↗
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
- Aptima Combo 2® KIT,APTIMACOMBO2,100T,REF,CEIVD-UPDATEDHologic, Inc. · DNA-REAGENTS, NEISSERIA3 reports
- BD Viper™ System 441091Becton, Dickinson And Company · DNA-REAGENTS, NEISSERIA3 reports
- Aptima® APTIMA VAGINAL SWAB COLLECTION KITHologic, Inc. · DNA-REAGENTS, NEISSERIA2 reports
- BD Viper™ System Remanufactured 442843Becton, Dickinson And Company · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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