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	07/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of bd max¿ gbs, a discrepant patient result was obtained.Initial test was gbs positive, but the repeat test was gbs negative.Result was confirmed to be gbs negative by culture.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 ; +1(410)316-4000
• MDR Report Key: 50303780
• Report Number: 3007420875-2026-00167
• Device Sequence Number: 16127726
• Product Code: OOI
• UDI-Device Identifier: 00382904417727
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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: 6007817
• 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: 07/24/2026
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2026
• 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