FDA Adverse Event
Malfunction
Summary report: N
BD MAX¿ VAGINAL PANEL
MDR report key: 24775967
·
Received April 3, 2026
Report
- Report Number
- 3007420875-2026-00074
- Event Type
- Malfunction
- Date Received
- April 3, 2026
- Date of Event
- March 2, 2026
- Report Date
- April 13, 2026
- Manufacturer
- GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
- Product Code
- OOI
- UDI-DI
- 00382904437121
- PMA / PMN Number
- K201017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
D.2. ADDITIONAL MEDICAL DEVICE TYPES: NSU, OUY, PQA. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A FALSE NEGATIVE BACTERIAL VAGINOSIS PATIENT RESULT WAS OBTAINED. CULTURE WAS GARDNERELLA POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 839463 | BD MAX¿ VAGINAL PANEL | VAGINITIS AND BACTERIAL VAGINOSIS NUCLEIC ACID DETECTION SYSTEM | OOI | GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) | 5077855 | 00382904437121 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |