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	11/24/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during use of bd max¿ gbs, a false positive patient result was obtained.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for discrepant results with the bd max¿ gbs assay (ref.(b)(4)) lot 5142282 was performed by the review of manufacturing records, review of customer¿s data and by the complaint¿s history review.The review of quality control records of bd max¿ gbs assay lot 5142282 revealed no anomalies that could explain the customer¿s false positive results.Customer provided run files of runs 1690 (initial run), 1691 (repeat test) and 1698 (environmental monitoring (em)) from bd max¿ instrument ct3088 for investigation and identified samples in positions a3 to a10 (run 1690) as the suspected false positive samples.Manual pcr curve adjudication showed early amplification for samples a3 and a9 in the fam channel (gbs target) in run 1690 and during their repeat test done in positions a3 and a9 of run 1691.These results appear to be true positive results, without issue.On the other hand, in initial (run 1690) and repeat test runs (new sbt; run 1691), samples a4, a5, a6, a7, a8 and a10 showed late amplification in the fam channel (gbs target).Such late ct values are unexpected with the gbs assay, since samples are tested following an enrichment step.Considering customer mentioned it was their first day of running the gbs assay, it is suspected cross-contamination occurred during sample preparation.Based on the data and information provided, cross contamination or specimens at or near the assay limit of detection (lod), are the most likely causes to explain the customer¿s positive results.However, although bd is unable to confirm the exact cause of the issue, no reagents issue is suspected.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max¿ gbs lot 5142282.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 since no new hazard was identified.
Event or Problem Description
It was reported that during use of bd max¿ gbs, a false positive patient result was obtained.There was no report of patient impact.

• 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: 23822985
• Report Number: 3007420875-2025-00257
• Device Sequence Number: 13252626
• Product Code: OOI
• UDI-Device Identifier: 00382904417727
• UDI-Public: (01)00382904417727(17)261219(10)5142282
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 02/06/2026

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: 5142282
• 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: 02/06/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2025
• 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