MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, Inc. (BD DIAGNOSTICS) BD MAX¿ EXT Enteric Bacterial Panel; Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

Catalog Number	443812
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information: d.4.Medical device lot: 6056731 d.4.Medical device expiration date: 08/28/2027 d.4.Unique identifier (udi) #: (b)(4).H.4.Device manufacture date: 03/02/2026 investigation summary: introduction: the complaint investigation for two events of suspected vibrio false positive results when using the bd max¿ extended enteric bacterial panel (xebp) assay (ref.(b)(4) kit lots 6013174 and 6056731 was performed by the review of manufacturing records, review of customer¿s data and by the complaint¿s history review.Batch history review: the review of quality control records of bd max¿ extended enteric bacterial panel kit lots 6013174 and 6056731 revealed no anomalies that could explain the customer¿s discrepant results.Investigational testing: the customer provided a pdf document listing all the vibrio positive results obtained since (b)(6) 2026 and two run files (run_240_2026-06-18_095339 and run_252_2026-06-17_180857) from bd max¿ instrument ct1554 for investigation.Analysis of the provided runs identified a vibrio-positive result in run #240 (position a5) using kit lot 6013174, and another vibrio-positive result in run #252 (position a4).Manual curve adjudication revealed late and low amplification curves in the rox channel (bot cartridge position) without any anomaly.The internal control amplification curves show no anomaly, suggesting no sample-related inhibition.Nevertheless, manual curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.The pdf provided by the customer indicated that several vibrio-positive samples showed late ct values, supporting the possibility of bacterial loads near the assay limit of detection.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max xebp assay lots 6013174 and 6056731.Conclusion: the root cause was not identified.However, based on the investigation, specimens containing non-viable bacterial dna or bacterial load at or near the assay limit of detection (lod), or environmental or cross contamination, are the most likely causes to explain the customer¿s discrepant results.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.
Event or Problem Description
It was reported that during use of bd max¿ ext enteric bacterial panel, a false positive vibrio patient result with an unusual pcr curve was obtained.There was no report of patient impact.

• Brand Name: BD MAX¿ EXT Enteric Bacterial 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 ; +1(410)316-4000
• MDR Report Key: 50022160
• Report Number: 3007420875-2026-00160
• Device Sequence Number: 10551410
• Product Code: PCH
• UDI-Device Identifier: 00382904438128
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K214122
• 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): 07/30/2026

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: 443812
• Device Lot Number: 6013174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2026
• Supplement Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2026
• 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