MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ VAGINAL PANEL; VAGINITIS AND BACTERIAL VAGINOSIS NUCLEIC ACID DETECTION SYSTEM

Catalog Number	443712
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of bd max¿ vaginal panel, a false negative trichomonas vaginalis (tv) patient result was obtained.Sample tested tv positive on bd max¿ ctgctv2 on 2 different bd max instruments, and tv negative on 2 different bd max instruments on bd max¿ vaginal panel.There was no report of patient impact.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for discrepant results when using the bd max¿ vaginal panel (ref.443712) lot 5050864 was performed by the review of manufacturing records, retain material testing and by the complaint¿s history review.The customer reported two suspected false negative results on bd max¿ vaginal panel (ref#443712) kit lot 5050864.According to customer, both samples were negative for the trichomonas vaginalis target (tv) and positive for the same target on kit bd max¿ ctgctv2 panel (ref#443904), with each sample tested twice on both assays.Customer was expecting the same result for the tv target with both assays.The review of quality control records of bd max¿ vaginal panel lot 5050864 revealed no anomalies that could explain the customer¿s discrepant result.The retain material of bd max¿ vaginal panel from lot 5050864 was tested and the results were as expected.Aside from the information available in the complaint text, no additional data was available for investigation.Without data no analysis was possible.It must be noted that lod can vary between different assays, including the tv target.Moreover, the concentration of target dna can differ between different specimens collected from the same patient.Furthermore, according to the package inserts for both the bd max¿ vaginal panel assay and the bd ctgc/tv2 assay for the bd max¿ system, a repeat should only be done when the result is ind, inc, or unr (for one or more targets).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 5050864.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and a preventive action plan since no new hazard or trends was identified.
Event or Problem Description
It was reported that during use of bd max¿ vaginal panel, a false negative trichomonas vaginalis (tv) patient result was obtained.Sample tested tv positive on bd max¿ ctgctv2 on 2 different bd max instruments, and tv negative on 2 different bd max instruments on bd max¿ vaginal panel.There was no report of patient impact.

• Brand Name: BD MAX¿ VAGINAL PANEL
• Common Device Name: VAGINITIS AND BACTERIAL VAGINOSIS NUCLEIC ACID DETECTION SYSTEM
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer (Section G): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 23707103
• Report Number: 3007420875-2025-00225
• Device Sequence Number: 16120470
• Product Code: PCH
• UDI-Device Identifier: 00382904437121
• UDI-Public: (01)00382904437121(17)260331(10)5050864
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K201017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: 443712
• Device Lot Number: 5050864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown