MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ GROUP B STREPTOCOCCUS; NUCLEIC ACID AMPLIFICATION ASSAY SYSTEM, GROUP B STREPTOCOCCUS, DIRECT SPECIMEN

Catalog Number	441772
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of bd max¿ gbs, a false positive patient result was obtained.Sample was cultured and was group b streptococcus negative.There was no report of patient impact.
Additional Manufacturer Narrative
D.2.Additional medical device type: njr.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

• Brand Name: BD MAX¿ GROUP B STREPTOCOCCUS
• Common Device Name: NUCLEIC ACID AMPLIFICATION ASSAY SYSTEM, GROUP B STREPTOCOCCUS, DIRECT SPECIMEN
• 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: 24857056
• Report Number: 3007420875-2026-00086
• Device Sequence Number: 10488708
• Product Code: OOI
• UDI-Device Identifier: 00382904417727
• UDI-Public: (01)00382904417727(17)270109(10)5154447
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111860
• 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): 05/08/2026

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: 441772
• Device Lot Number: 5154447
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2025
• 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