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	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
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 (us), a false positive gonorrhea patient result was obtained.Sample was repeated on bd max twice and was negative for both.There was no report of patient impact.
Event or Problem Description
It was reported that during use of bd max¿ ctgctv2 (us), a false positive gonorrhea patient result was obtained.Sample was repeated on bd max twice and was negative for both.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for discrepant results when using the bd ctgctv2 for bd max¿ system kit (ref.(b)(4)) from lot 5183346 was performed by the review of manufacturing records, review of customer¿s data and by the complaint¿s history review.Customer complained about discrepant results for the neisseria gonorrhoeae (gc) target for one sample which was initially positive but gave negative results upon two retests from same sbt.Customer provided runs 2844, 2845, 2847 and 2848 from bd max¿ instrument (b)(6) for investigation.Affected samples were found in positions b11 (gc pos) of run 2844, b10 (gc neg) of run 2845 and b10 (gc neg) of run 2847, when testing the same sample buffer tube (sbt) from initial sample, and in positions b2 and b12 (gc neg) in run 2848, when testing recollected samples.Manual pcr curves adjudications revealed late and low but true amplifications in the vic and cy5.5 channels (gc targets) for sample b11 (run 2844) and gave a positive gc result, while amplification was only observed in the vic channel (gc target) for sample b10 (run 2845), which resulted in a negative gc result since both targets are required to give a positive gc target result.No amplification was observed in the vic nor the cy5.5 channels for samples b10 (run 2847) and b2/b12 (run 2848).Nevertheless, manual curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.The root cause was not identified.Based on the data and information provided, specimens at or near the assay limit of detection (lod), or environmental or cross contamination, are the most likely causes to explain the customer¿s positive results.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 5183346.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: 23828493
• Report Number: 3007420875-2025-00264
• Device Sequence Number: 15770094
• Product Code: LSL
• UDI-Device Identifier: 00382904439040
• UDI-Public: (01)00382904439040(17)261226(10)5183346
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 02/04/2026

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: 5183346
• 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: 02/04/2026
• 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: 07/02/2025
• 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