MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ ENTERIC VIRAL PANEL; GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM

Catalog Number	443985
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for discrepant results with the bd max¿ enteric viral panel kit (ref.443985) lot 5021182 was performed by the review of manufacturing records, customer¿s data analysis and verification of complaints history.The review of quality control records of bd max¿ enteric viral panel kit lot 5021182 revealed no anomalies that could explain the customer¿s discrepant results.Customer reported an increase in positive results that were found to be mostly false positive results and provided run files (pdf and csv) of run 1302 from bd max¿ instrument ct2482 for investigation.No samples were identified by the customer.The six positive samples found in run 1302 were analyzed (b5, b6, b8, b9, b10, b11).Manual pcr curve adjudication showed true amplification for sample b5 in the fam channel in the top position of the cartridge (rotavirus (rov) target), sample b6 in the vic channel in bottom position of the cartridge (sapovirus (sav) target) and samples b8/b9 in the fam channel in top position of the cartridge (rotavirus (rov) target).However, preliminary analysis for samples b8 top (adenovirus (adv) target) and b9 top/bottom (adv and sav targets respectively) suggests a possible optical crosstalk issue.It is unlikely these positive results (b8 adv pos and b9 adv and sav pos results) are true amplifications.This information was transferred to bd service for further investigation, and a service case has been opened on the instrument ct2482.Samples b10 and b11, on the other hand, showed step dislocations in multiple channels resulting in fluorescence reaching the threshold to give a positive result in the rox channel, in bottom (astrovirus (hastv) target) and top (norovirus (nov) target) positions of the cartridge, respectively.It is unlikely these positive results are true amplifications.Unfortunately, no root cause could be identified but the issue seemed isolated to these two events.Nevertheless, it must be noted that manual curve adjudication has limitations; visual examination of pcr curves for low signal and aberrant curve geometry are a conservative assessment of the data.Overall, based on the data provided, bd was unable to find the exact cause of why some of the customer¿s positive results appear to be false.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max¿ enteric viral panel assay lot 5021182.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action (capa) since no new hazard was identified.
Event or Problem Description
Report 4 of 6: it was reported that during use of bd max¿ enteric viral panel, a false positive patient result was obtained.There was no report of patient impact.

• Brand Name: BD MAX¿ ENTERIC VIRAL PANEL
• Common Device Name: GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY 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: 24261922
• Report Number: 3007420875-2026-00008
• Device Sequence Number: 15831081
• Product Code: OOI
• UDI-Device Identifier: 00382904439859
• UDI-Public: (01)00382904439859(17)260822(10)5021182
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K220607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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 Expiration Date: 08/22/2026
• Device Catalogue Number: 443985
• Device Lot Number: 5021182
• 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: 01/28/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2025
• 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