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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during use of bd max¿ vaginal panel, a discrepant bacterial vaginosis (bv) patient result was obtained.Initial run gave trichomonas vaginalis (tv) positive and bv negative results.Repeat on the same bd max¿ instrument gave tv and bv positive results.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for discrepant results when using the bd max¿ vaginal panel (ref.443712) kit lot 5262896 was performed by the review of manufacturing records, review of customer¿s data 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 discrepant result for the bacterial vaginosis (bv) target: the initial test was negative for the bv target along a positive trichomonas vaginalis (tv) target result, while a repeat test performed from the same sbt yielded a positive result for the bv target was obtained with the tv target which remained positive.For the investigation, the customer provided the run files for bd max¿ instrument (b)(6) (runs 2773 and 2775) and identified the samples in positions b5 (run 2773; initial negative) and b4 (run 2775; repeat positive) as the samples associated with the discrepancy.Manual pcr curves adjudication was performed for the bv discrepant samples, both showed similar early amplification of the atopobium vaginae target (avag; fam channel), while no other target reached a valid cycle-threshold for both initial and repeat testing.However, in the initial testing, the amplification of avag target was slightly lower (higher ct) than the repeat testing, which resulted in the sample being just under the threshold to obtain a bv positive result.According the assay instruction for use, the bd max¿ vaginal panel provides qualitative results reported based on detection and quantitation of targeted organism markers (uses a proprietary semi quantitative algorithm to determine bv status based on the relative quantities of lactobacillus crispatus / l.Jensenii, gardnerella vaginalis, atopobium vaginae, bvab 2 and megasphaera 1 targets) and in this sample the ct cut-off to obtain a positive bv result was at a value in-between both samples, indicating that the sample is at a concentration at the limit of detection of the assay (lod), explaining the customer¿s discrepant results between initial and repeat test.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.The root cause was not identified.However, specimen at or near the assay limit of detection (lod) could explain the customer's discrepant results.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 discrepant bacterial vaginosis (bv) patient result was obtained.Initial run gave trichomonas vaginalis (tv) positive and bv negative results.Repeat on the same bd max¿ instrument gave tv and bv positive 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: 24456398
• Report Number: 3007420875-2026-00035
• Device Sequence Number: 9968793
• Product Code: OOI
• UDI-Device Identifier: 00382904437121
• UDI-Public: (01)00382904437121(17)260922(10)5262896
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 03/03/2026

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: 01/30/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2025
• 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