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	02/06/2026
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 trichomonas vaginalis (tv) patient result was obtained.Sample was repeated on bd max¿ vaginal panel, and the result was tv negative.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 trichomonas vaginalis (tv) patient result was obtained.Sample was repeated on bd max¿ vaginal panel, and the result was tv negative.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)) lot 5204477 was performed by the review of manufacturing records, review of customer¿s data, retain material testing and by the complaint¿s history review.The review of quality control records of bd ctgctv2 for bd max¿ system kit lot 5204477 revealed no anomalies that could explain the customer¿s unr results.The retain material of bd ctgctv2 for bd max¿ system kit from lot 5204477 was tested and the results were as expected.Customer reported an unr result for a sample tested with bd ctgctv2 for bd max system kit lot 5204477, which obtained a negative and an indeterminate result upon two retests.Customer provided four runs (#841, 842, 844 and 845) from bd max¿ instrument ct2176 for investigation.Sample in position b8 from run #842 obtained an unr result.Manual pcr curve adjudication of the unr sample revealed lower raw fluorescence and absence of amplification of internal control (rox channel).An unr result is what is expected in such cases.According to the instruction for use (p0237) an unresolved result could be indicative of specimen-associated inhibition.Retest of this patient urine sample was found in position a7 in run #844 using a new sbt and obtained a negative result.Manual pcr curve adjudication of this sample revealed no anomaly.According to the customer, the sample was repeated a second time and produced an indeterminate (ind) result; however, no data corresponding to this repeat test could be identified in the available runs.There is no indication of a reagent issue based on the analysis of the complaints received for unresolved result on bd ctgctv2 for bd max¿ system kit lot 5204477.The root cause was not identified.However, sample related inhibition is the most likely cause to explain the customer¿s unresolved result.No anomalies were identified for the negative repeat result, and the indeterminate result could not be further investigated since no data was available.Nonetheless, based on the investigation, 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.

• 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: 24533760
• Report Number: 3007420875-2026-00040
• Device Sequence Number: 8972116
• Product Code: LSL
• UDI-Device Identifier: 00382904439040
• UDI-Public: (01)00382904439040(17)270123(10)5204477
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 04/08/2026

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: 5204477
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2025
• 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