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	04/10/2026
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, an unspecified number of low false positive norovirus and rotovirus patient results were obtained.Low positive samples were retested and were negative.There was no report of patient impact.
Event or Problem Description
It was reported that during use of bd max¿ enteric viral panel, an unspecified number of low false positive norovirus and rotovirus patient results were obtained.Low positive samples were retested and were negative.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: introduction the complaint investigation for an increased frequency of low positive results for norovirus and rotavirus targets when using the bd max¿ enteric viral panel assay (ref.(b)(4)) from lot 5262940 was performed by the review of manufacturing records and the complaint¿s history review.Batch history review: the review of quality control records of bd max¿ enteric viral panel assay lot 5262940 revealed no anomalies that could explain the customer¿s discrepant results.Investigational testing: despite multiple attempts made to receive information, no data was available for the investigation.As a result, no further analysis could be performed and the root cause could not be determined.Nevertheless, considering that the customer is experiencing the same issue across five different bd max¿ enteric viral panel lots and two separate bd max¿ instruments, a reagent- or instrument-related cause is unlikely.There is no indication of a reagent issue based on the analysis of the complaints received for low positive results on bd max¿ enteric viral panel assay lot 5262940.Conclusion: 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 since no trend was identified.

• 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: 25085968
• Report Number: 3007420875-2026-00110
• Device Sequence Number: 21434915
• Product Code: OOI
• UDI-Device Identifier: 00382904439859
• UDI-Public: (01)00382904439859(17)270515(10)5262940
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 05/20/2026

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: 443985
• Device Lot Number: 5262940
• 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: 04/10/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2025
• 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