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	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.2.Additional medical device type: pch.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¿ enteric viral panel, a false positive norovirus patient result with a week pcr curve was obtained.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for discrepant results with the bd max¿ enteric viral panel kit (ref.(b)(4)) lot 5021181 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 5021181 revealed no anomalies that could explain the customer¿s discrepant results.Customer reported false positive results for norovirus (nov) with the bd max¿ enteric viral panel.According to customer, there was no real amplification or no sigmoidal curves, and sometimes bubbles could be observed in cartridges.Customer provided run files (pdf) of run runs 488 from bd max¿ instrument ct3307 for investigation.Samples in run 488 in positions a4 and a5 were identified as problematic by the customer.Manual pcr curve adjudication revealed step dislocations in multiple channels were observed, and it is unlikely these positive results are true amplifications.These results could be related to the bubbles the customer mentioned having observed in the cartridges, since multiple channels are impacted at the same cycle.Overall, bd was unable to find the exact cause of the customer¿s positive results, but based on the investigation, 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 bd max¿ enteric viral panel assay lot 5021181.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 2 of 2: it was reported that during use of bd max¿ enteric viral panel, a false positive norovirus patient result with a week pcr curve 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: 23828881
• Report Number: 3007420875-2025-00266
• Device Sequence Number: 9267882
• Product Code: OOI
• UDI-Device Identifier: 00382904439859
• UDI-Public: (01)00382904439859(17)260808(10)5021181
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 02/02/2026

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: 08/08/2026
• Device Catalogue Number: 443985
• Device Lot Number: 5021181
• 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: 02/02/2026
• 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: 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