MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ CTGCTV2 (US); MULTIPLE-TYPE SEXUALLY TRANSMITTED PATHOGEN NUCLEIC ACID IVD KIT

Catalog Number	443904
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	03/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of bd max¿ ctgctv2, a trichomonas vaginalis (tv) discrepant patient result was obtained.Initial result was tv positive.Test was repeated and was tv negative.There was no report of patient impact.
Additional Manufacturer Narrative
D.2.Additional medical device types: mkz, ouy.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¿ ctgctv2, a trichomonas vaginalis (tv) discrepant patient result was obtained.Initial result was tv positive.Test was repeated and was tv negative.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: introduction: the complaint investigation for discrepant results when using the bd ctgctv2 for bd max¿ system kit (ref.(b)(4)) from lot 5224008 was performed by the review of manufacturing records, review of customer¿s data and by the complaint¿s history review.Batch history review: the review of quality control records of bd ctgctv2 for bd max¿ system kit lot 5224008 revealed no anomalies that could explain the customer¿s discrepant results.Investigational testing: customer complained about discrepant results for t.Vaginalis (tv) target with the bd ctgctv2 for bd max¿ system.The initial test (run #2383/b9) gave a positive result for the tv target, while repeat tests gave unresolved (unr, in run #2388/a12) and negative results (run #2390/a1) respectively.Customer provided runs #2383, 2388 and 2390 from bd max¿ instrument ct2473 for investigation.Manual pcr curve adjudication revealed late and low amplification in the cy5 channel (tv target) for sample b9 in run 2383.Such a low positive sample can occur due to bacterial titers in the specimen being at or near the limit of detection of the assay or through environmental or cross contamination introduced during the sample preparation at the customer¿s site.Samples a12 (run 2388) and a1 (run 2390) were addressed in a previous complaint.Nevertheless, manual curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on the bd ctgctv2 for bd max¿ system kit lot 5224008.Conclusion: the root cause was not identified.Based on the data and information provided, specimens at or near the assay limit of detection (lod), is the most likely causes to 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 plan since no new hazard was identified.

• Brand Name: BD MAX¿ CTGCTV2 (US)
• Common Device Name: MULTIPLE-TYPE SEXUALLY TRANSMITTED PATHOGEN NUCLEIC ACID IVD KIT
• 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: 24965773
• Report Number: 3007420875-2026-00103
• Device Sequence Number: 18765981
• Product Code: LSL
• UDI-Device Identifier: 00382904439040
• UDI-Public: (01)00382904439040(17)270501(10)5224008
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K182692
• 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): 05/08/2026

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 Catalogue Number: 443904
• Device Lot Number: 5224008
• 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: 03/27/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2025
• 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