Control Set for the BD ProbeTec™ (CT/GC) 441125Recalls & reported problems
Becton, Dickinson And Company · Set CT/GC Qx Control · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382904411251), received between Feb 10, 2021 and Mar 18, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K081825); they may or may not involve this specific model.
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
- Device Markings/Labelling Problem1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT PRIOR TO USE, A CONTROL SET FOR THE BD PROBETEC¿ (CT/GC) QX AMPLIFIED DNA ASSAYS HAD A LABEL WITH MISSING BARCODE, LOT NUMBER, AND EXPIRATION DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18924754 ↗MalfunctionFeb 10, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING CONTROL SET FOR THE BD PROBETEC¿ (CT/GC) QX AMPLIFIED DNA ASSAYS 4 FALSE NEGATIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11308646 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K081825. One submission often covers many models, so check the product and lot details in each record.
- Z-1215-2013 · Feb 8, 2013 · TerminatedBD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amp
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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