MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD Veritor¿ System for Rapid Detection of Group A Strep CLIA-Waived Kit; ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Catalog Number	256040
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: introduction: material #: 256040 batch #: 5293908 defect: the customer reported that they received false negative results.The veritor test produced a negative result, while subsequent testing of the same patient using a strepaim test kit yielded a positive result.Investigational testing / review: bd quality performs a systematic approach to investigate all complaints.This approach involves review of manufacturing batch history records, retention sample testing if applicable, and visual inspection of customer returned samples if applicable.Retain sample testing was performed on the batch number provided.The results were acceptable.The reported issue was not able to be replicated.Batch history review: batch history record (bhr) review was performed on the batch number provided.The results were acceptable and no relevant issues were found.Returned material analysis: there were return samples received and functionally tested.All results are passing and acceptable.The reported issue cannot be confirmed.Complaint history review: a trend analysis for false negative was conducted, no adverse trend was identified.Conclusion: the reported issue was unable to be confirmed.There were no corrective actions taken at this time.
Event or Problem Description
It was reported while using the bd veritor¿ system for rapid detection of group a strep clia-waived kit, a negative result for group a strep was obtained on one (1) patient test cartridge from a veritor analyzer.The customer then tested the patient using the strepaim test kit, which provided a positive result for group a strep.A second specimen was also collected from the patient for repeat testing on a veritor analyzer.The patient was symptomatic and treated based on their clinical presentation.There were no health impact or consequences reported.

• Brand Name: BD Veritor¿ System for Rapid Detection of Group A Strep CLIA-Waived Kit
• Common Device Name: ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer (Section G): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; +1(410)316-4000
• MDR Report Key: 50856442
• Report Number: 3006948883-2026-00598
• Device Sequence Number: 9553988
• Product Code: GTY
• UDI-Device Identifier: 00382902560401
• UDI-Public: (01)00382902560401(17)280707(10)5293908
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K122718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 256040
• Device Lot Number: 5293908
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2025
• 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