BD MAX¿ VAGINAL PANEL
Report
- Report Number
- 3007420875-2025-00267
- Event Type
- Malfunction
- Date Received
- December 17, 2025
- Date of Event
- November 25, 2025
- Report Date
- January 28, 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
- UT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD MAX¿ VAGINAL PANEL (REF. (B)(4)) LOT 5142281 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, CUSTOMER¿S DATA ANALYSIS AND VERIFICATION OF COMPLAINTS HISTORY. THE REVIEW OF QUALITY CONTROL RECORDS OF BD MAX¿ VAGINAL PANEL LOT 5142281 REVEALED NO ANOMALIES THAT COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. CUSTOMER PROVIDED DATABASE FROM BD MAX¿ INSTRUMENT CT3055 AND IDENTIFIED SAMPLE TESTED IN POSITION A12 (RUN 6645; INITIAL TEST) AND B3 (RUN 6648; REPEAT TEST) AS THE DISCREPANT SAMPLES. THE INITIAL TEST IN RUN 6645 GENERATED POSITIVE RESULTS FOR ALL TARGETS, WHILE THE REPEAT TEST SHOWED POSITIVITY ONLY FOR THE BV TARGET, SUGGESTING A POTENTIAL ISSUE WITH THE AMPLIFICATION REACTIONS IN THE WELL LOCATED AT THE BOTTOM OF THE CARTRIDGE FOR THE INITIAL TESTING. CURVE ANALYSIS INDICATED THAT ALL THE TARGETS POSITIONED IN THE BOTTOM WELL OF THE CARTRIDGE IN RUN 6645 (CGROUP (ROX CHANNEL), CKRU (CY5 CHANNEL), CGLA (VIC CHANNEL), TV (FAM CHANNEL), AND THE INTERNAL CONTROL (CY5.5 CHANNEL) ALL DISPLAYED IDENTICAL STEP DISLOCATIONS AND ATYPICAL, NON-SIGMOIDAL CURVES. THESE PATTERNS ARE UNLIKELY TO REPRESENT TRUE AMPLIFICATION. MOREOVER, ANALYSIS OF THE REPEAT TEST (RUN 6648, POSITION B3) SHOWED EXPECTED AMPLIFICATION, WITHOUT ANOMALY, IN THE CY5.5 CHANNEL (INTERNAL CONTROL) ONLY, WITH NO AMPLIFICATION OBSERVED IN THE OTHER CHANNELS. DATABASE ANALYSIS REVEALED THAT IN 2025, THE CUSTOMER REPORTED A TOTAL OF THREE SUSPECTED FALSE POSITIVE RESULTS AMONG MORE THAN 27000 TESTS PERFORMED, REPRESENTING A NEGLIGEABLE PROPORTION OF THEIR TOTAL TESTING VOLUME. THE ISSUE SEEMED ISOLATED TO THOSE EVENTS. NEVERTHELESS, IT MUST BE NOTED THAT MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. ALTHOUGH, BASED ON THE DATA AND INFORMATION PROVIDED, NO ROOT CAUSE WAS IDENTIFIED AND UPON INVESTIGATION, NO REAGENTS ISSUE IS SUSPECTED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX¿ VAGINAL PANEL LOT 5142281. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) SINCE NO NEW HAZARD WAS IDENTIFIED.
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A PATIENT SAMPLE WAS POSITIVE FOR ALL TARGETS. SAMPLE WAS REPEATED ON BD MAX AND WAS ONLY POSITIVE FOR BACTERIAL VAGINOSIS. THERE WAS NO REPORT OF PATIENT IMPACT.
IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A PATIENT SAMPLE WAS POSITIVE FOR ALL TARGETS. SAMPLE WAS REPEATED ON BD MAX AND WAS ONLY POSITIVE FOR BACTERIAL VAGINOSIS. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2247800 | BD MAX¿ VAGINAL PANEL | VAGINITIS AND BACTERIAL VAGINOSIS NUCLEIC ACID DETECTION SYSTEM | OOI | GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) | 5142281 | 00382904437121 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |