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	01/21/2026
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, a false positive norovirus patient result was obtained.Test was repeated on max and was norovirus negative.There was no report of patient impact.
Event or Problem Description
It was reported that during use of bd max¿ enteric viral panel, a false positive norovirus patient result was obtained.Test was repeated on max and was norovirus negative.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: introduction: the complaint investigation for false positive results with the bd max¿ enteric viral panel kit (ref.(b)(4)) lot 5262938 was performed by the review of manufacturing records, customer¿s data analysis and verification of complaints history.Batch history review: the review of quality control records of bd max¿ enteric viral panel kit lot 5262938 revealed no anomalies that could explain the customer¿s discrepant results.Investigational testing: customer reported a suspected norovirus (nov) target false positive result from the sample patient sample, which according to customer were associated to questionable curves.Customer provided run 534 from the bd max¿ instrument ct3307 and run #961 from the bd max¿ instrument ct3222 for investigation.Customer identified the affected samples as a1/run 534 and a10/run 961.Manual pcr curve adjudication showed a step dislocation in the raw pcr signal, resulting in a positive result for the nov target in both samples.The pattern of step dislocations was observed in all the target channels (fam, rox and vic) in top, with the curve for the norovirus target (rox-top) reaching the threshold to be valid, resulting in a positive result.It is unlikely this positive result in both runs is due to true amplification.Unfortunately, no root cause could be identified but the issue with step dislocations from an unknown origin causing a positive result seemed isolated to this event.Moreover, since both samples were from the same patient sample, it suggests an issue with the sample itself.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 5262938.Conclusion: bd was unable to find the exact cause of the customer¿s positive results, but based on the investigation, no reagents issue is suspected.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.

• 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: 24367787
• Report Number: 3007420875-2026-00021
• Device Sequence Number: 13174769
• Product Code: OOI
• UDI-Device Identifier: 00382904439859
• UDI-Public: (01)00382904439859(17)270424(10)5262938
• 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): 04/23/2026

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: 5262938
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 05/01/2026
• 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