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	12/19/2025
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 trichomonas vaginalis false positive patient result was obtained.The first test on the bd max¿ vaginal panel was dual positive for bacterial vaginosis (bv) and trichomonas vaginalis (tv).The second test on bd max¿ vaginal panel was bv positive, but tv negative.Test was repeated on bd max¿ ctgctv2 and was all negative.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.(b)(4)) kit lot 5142281 was performed by the review of customer¿s data, review of manufacturing records and by the complaint¿s history review.Customer reported a suspected false positive result on bd max¿ vaginal panel (ref#(b)(4)) kit lot 5142281.According to customer, the sample was positive for the trichomonas vaginalis target (tv) and negative upon repeat.The sample was also tested on bd ctgctv2 for bd max¿ system (ref#(b)(4)) and the result was still negative for the tv target.The initial sample was in run 2342 from the bd max¿ instrument (b)(6) and according to customer was positive for bacterial vaginosis as well as positive for trichomonas vaginalis.However, this run was not provided.The repeat on bd max¿ vaginal panel was performed in run 2223 of bd max¿ instrument (b)(6) and was retrieved from the database for analysis.The affected sample accession id, which refers to the last three digits *828, was found in position a3.The run number for the repeat with the bd ctgctv2 for bd max¿ system was not named in the complaint and the sample accession id was not found associated with a ctgctv2 sample on bd max¿ instrument (b)(6).Manual pcr curves adjudication of the repeat test (sample a3; run 2223) showed true amplification for the tv target, but was late and low and did not reach the thresholds to be positive.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.Based on the data analysis and information provided, a specimen at or near the assay limit of detection (lod) is the most likely cause to explain the customer¿s discrepant result between initial and repeat test of that sample.Limit of detection can vary between different assays.As stated in the bd max¿ vaginal panel ifu (p0258(05)), 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 test.Moreover, 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.Moreover, limit of detection can vary between different assays.The positive result from the initial sample is suspected of being a true positive from a specimen at or near the assay limit of detection since the repeat of the sample (a3, run 2473) showed true amplification which did not reach the threshold to be positive.The review of quality control records of bd max¿ vaginal panel lot 5142281 revealed no anomalies that could explain the customer¿s discrepant result.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 5142281.The root cause was not identified.However, specimens at or near the assay limit of detection (lod) is suspected of having contributed to the customer¿s discrepant results.Nonetheless, no reagents issue is suspected.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 false positive patient result was obtained.The first test on the bd max¿ vaginal panel was dual positive for bacterial vaginosis (bv) and trichomonas vaginalis (tv).The second test on bd max¿ vaginal panel was bv positive, but tv negative.Test was repeated on bd max¿ ctgctv2 and was all negative.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: 24251873
• Report Number: 3007420875-2026-00004
• Device Sequence Number: 12848652
• Product Code: OOI
• UDI-Device Identifier: 00382904437121
• UDI-Public: (01)00382904437121(17)260519(10)5142281
• 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): 03/23/2026

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: 01/07/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2025
• 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