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	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• 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: 23828500
• Report Number: 3007420875-2025-00267
• Device Sequence Number: 9268298
• Product Code: OOI
• UDI-Device Identifier: 00382904437121
• UDI-Public: (01)00382904437121(17)260519(10)5142281
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 01/28/2026

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: 05/19/2026
• Device Catalogue Number: 443712
• Device Lot Number: 5142281
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2025
• 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