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 Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction

• 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 ; +1(410)316-4000
• MDR Report Key: 50858505
• Report Number: 3007420875-2026-00183
• Device Sequence Number: 18530302
• Product Code: OOI
• UDI-Device Identifier: 00382904417727
• 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
• Report Date (Section B): 08/31/2026

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: 6048746
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2026
• 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