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	11/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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¿ ext enteric bacterial panel, a false positive vibrio patient result with a week pcr curve was obtained.There was no report of patient impact.
Event or Problem Description
It was reported that during use of bd max¿ ext enteric bacterial panel, a false positive vibrio 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 result with the bd max¿ extended enteric bacterial panel kit (ref.(b)(4)) lot 4257179 was performed by the review of manufacturing records, review of customer¿s data and by the complaint¿s history review.Customer complained about suspected false positive results for the vibrio target when using the bd max¿ extended enteric bacterial panel kit lot 4257179.According to customer, the curves were doubtful with high ct and no real amplification.The review of quality control records of bd max¿ extended enteric bacterial panel kit lot 4257179 revealed no anomalies that could explain the customer¿s discrepant results.Customer provided runs files 1254, 886 and 483 from bd max¿ instruments (b)(6) respectively, for investigation.Positive vibrio results were found in positions a12/b6 (run 1254), b1/b2 (run 886) and b5 (run 483) and were investigated.Manual pcr curve adjudication was performed and showed late and low amplification that reached the threshold to give a positive result for sample a12 (run 1254), the expected result in such a case, without anomaly.Samples b6 (run 1254), b1/b2 (run 886) and b5 (run 483) showed step dislocations in multiple channels which does not suggest true amplification.Manual curve adjudication has limitations; visual examination of pcr curves for aberrant curve geometry is a conservative assessment of the data but based on the analysis.Based on the investigation, no anomaly was identified to explain the customer¿s discrepant result.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max¿ extended enteric bacterial panel kit lot 4257179.The root cause was not identified.No other complaint for this defect was received on this lot, thus the issue appears to be an isolated event.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action plan since no new hazard was identified.

• 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 ; 4103164000
• MDR Report Key: 23828128
• Report Number: 3007420875-2025-00250
• Device Sequence Number: 20100571
• Product Code: PCH
• UDI-Device Identifier: 00382904438128
• UDI-Public: (01)00382904438128(17)260328(10)4257179
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/11/2026

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: 03/28/2026
• Device Catalogue Number: 443812
• Device Lot Number: 4257179
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2024
• 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