MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ ENTERIC PARASITE PANEL; GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM

Catalog Number	442960
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Report 1 of 3: it was reported that during use of bd max¿ enteric parasite panel, a false positive giardia patient result was obtained.Test was repeated with a new reagent kit lot and was giardia positive.Test was then repeated with the same reagent kit lot and was giardia negative.There was no report of patient impact.
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.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for false positive results when using the bd max enteric parasite panel assay ref 442960 lot 5097004 was performed by the review of manufacturing records customer data analysis and verification of complaints history the review of quality control records of bd max enteric parasite panel lot 5097004 revealed no anomalies that could explain the customers false positive results customer reported three suspected false positive results for g lamb target when using the bd max enteric parasite panel kit lot 5097004 the customer provided the database from instrument (b)(6) for investigation and it was analyzed three incident dates were initially identified (b)(6) although no positive g lamb results were recorded on (b)(6) a positive result was obtained on (b)(6) and this result was included in the investigation alongside the two others manual pcr adjudication was performed for the three runs 5776 position a7 5779 position b5 and 5783 position b7 for all three samples the raw pcr signal showed step dislocations in the g lamb target fam channel reaching the thresholds to be considered a positive result similar step dislocations were also visible in the ehist vic channel and crypto rox channel targets the observed patterns suggest that the g lamb positive results are not consistent with true amplification in contrast the spc target displayed normal sigmoid amplification curves without any anomalies during the review of the database it was observed that since may 2025 there was an increase in weak positive results for this target most of which display step dislocated curves across all channels moreover the total number of g lamb positive results has risen during the same period despite the overall testing volume remaining relatively stable more than five different enteric parasite panel kit lots have been used since then indicating that the issue is unlikely to be linked to a specific lot or reagent an instrument service case is currently open for false positive issue and further investigations will be conducted it must be noted that manual curve adjudication has limitations visual examination of pcr curves for low signal or aberrant curve geometry is a conservative assessment of the data there is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max enteric parasite panel assay lot 5097004 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 trend was identified.
Event or Problem Description
Report 1 of 3: it was reported that during use of bd max¿ enteric parasite panel, a false positive giardia patient result was obtained.Test was repeated with a new reagent kit lot and was giardia positive.Test was then repeated with the same reagent kit lot and was giardia negative.There was no report of patient impact.

• Brand Name: BD MAX¿ ENTERIC PARASITE 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: 23979865
• Report Number: 3007420875-2025-00272
• Device Sequence Number: 10717028
• Product Code: OOI
• UDI-Device Identifier: 00382904429607
• UDI-Public: (01)00382904429607(17)261024(10)5097004
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K220193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: 442960
• Device Lot Number: 5097004
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• 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