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

Catalog Number	443979
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	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.2.Additional medical device types: mkz, ouy, qep 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 discrepant chlamydia trachomatis (ct) patient result was obtained.Sample initially tested ct positive.Sample was then repeated and was ct negative.There was no report of patient impact.
Event or Problem Description
It was reported that during use of bd max¿ ctgctv2, a discrepant chlamydia trachomatis (ct) patient result was obtained.Sample initially tested ct positive.Sample was then repeated and was ct negative.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for discrepant results when using bd cor¿ ctgctv2 (ref.443979) from kit lot 5237366 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 the individual components (master mix plates lot 5224487, extraction plates lot 5225443 and liquid reagent plates lot 5232273) included in bd cor¿ ctgctv2 lot 5237366 revealed no anomalies that could explain the customer¿s discrepant results.The customer reported a discrepant result in which a sample initially tested positive for the chlamydia trachomatis (ct) target, whereas repeat testing produced a negative result.Customer provided runs from 2026-feb-23 and 2026-feb-24 from bd cor¿ instrument crm0115 for investigation.The sample suspected of discrepancy, was found in the run completed on 23-02-2026 13:08:27, in position bota01.The same sample buffer tube was repeated in the run completed on 24-02-2026 10:35:59, in position bota10.Manual pcr curves adjudication was done and for the first test, the amplification curve in the fam channel (ct target) revealed late and low, but true amplification without any anomaly, whereas the repeat test showed a flat curve, again without anomaly.Positive and negative controls included in the repeat run completed on february 24 presented amplification curves as expected, suggesting no reagent issue.Moreover, in both runs, the internal control in the rox channel showed amplification values as expected, further supporting that no reagent issue occurred.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), or environmental or cross contamination, are the most likely causes to explain the customer¿s positive result in the initial test.Nonetheless, 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 all bd cor¿ ctgctv2 component lots used by the customer.The root cause was not identified.Bd did not initiate a corrective and preventive action since no new hazard was identified.

• Brand Name: BD MAX¿ CTGCTV2
• 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: 24716087
• Report Number: 3007420875-2026-00068
• Device Sequence Number: 5763189
• Product Code: LSL
• UDI-Device Identifier: 00382904439798
• UDI-Public: (01)00382904439798(17)20260911(10)5237366
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K210585
• 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): 04/09/2026

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: 09/11/2026
• Device Catalogue Number: 443979
• Device Lot Number: 5237366
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2025
• 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