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 Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of bd max¿ vaginal panel, a trichomonas vaginalis (tv) false positive patient result was obtained.An e-swab vaginal sample was collected and sent to an independent lab where quantstudio vaginal panel was tv negative.Second specimen was collected and tested and also gave tv negative results.There was no report of patient impact.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for discrepant results when using the bd max vaginal panel kit (ref.(b)(4)) kit lot 5262896 was performed by the review of manufacturing records and by the complaint's history review.The review of quality control records of bd max vaginal panel lot 5262896 revealed no anomalies that could explain the customer¿s discrepant results.Customer reported a suspected false positive result for the trichomonas vaginalis (tv) target while using the bd max¿ vaginal panel, kit lot 5262896.A same day e swab was sent at an external laboratory and yielded negative results for all targets.Two weeks later, a second specimen from the same patient was tested on the same bd max instrument using the same bd max vaginal panel kit lot and again produced a positive tv result, while testing at the external laboratory remained negative for all targets.Despite multiple attempts made to receive information, no data was available for the investigation.Without data, bd is unable to identify the cause of the customer issue.The customer later reported that the issue was with the other lab results but did not specify the cause.According to the instruction for use, erroneous test results may occur from improper specimen collection, handling or storage, technical error, sample mix-up or because the number of organisms in the sample is below the analytical sensitivity of the assay.As with all pcr-based tests, extremely low levels of target below the limit of detection of the assay may be detected, but results may not be reproducible.It must also be noted that limit of detection can vary between different assays and testing methods.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max vaginal panel kit lot 5262896.Overall, based on the review of manufacturing records and complaints history review, no bd max vaginal panel kit reagent related issue is suspected.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 since no new hazard was identified.
Event or Problem Description
It was reported that during use of bd max¿ vaginal panel, a trichomonas vaginalis (tv) false positive patient result was obtained.An e-swab vaginal sample was collected and sent to an independent lab where quantstudio vaginal panel was tv negative.Second specimen was collected and tested and also gave tv negative results.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: 24808052
• Report Number: 3007420875-2026-00082
• Device Sequence Number: 9620735
• Product Code: OOI
• UDI-Device Identifier: 00382904437121
• UDI-Public: (01)00382904437121(17)260922(10)5262896
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/09/2026

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: 09/22/2026
• Device Catalogue Number: 443712
• Device Lot Number: 5262896
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• 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