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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 while using the bd veritor¿ system for rapid detection of group a strep clia-waived kit, one (1) group strep a negative patient result was obtained from a veritor analyzer.The same patient test cartridge was re-inserted back into a veritor analyzer and a group strep a positive result was obtained.No confirmatory testing was reported.It should be noted the action of reinserting a used test cartridge is considered off-label use of the product.The physician treated the patient based on symptoms and no health impact or consequences were reported.
Additional Manufacturer Narrative
Investigation summary - this statement summarizes the investigation results regarding a complaint that alleges discrepant result when using kit grp a strep 30 test veritor (material#: 256040), batch number 5058322.The customer reported that they initially received a negative result with a patient sample.They re-inserted the same cartridge which then produced a positive result.Bd quality performs a systematic approach to investigate all complaints.This approach involves review of manufacturing batch history records, visual inspection of retention samples, and visual inspection of customer returned samples, if applicable.Batch history record (bhr) review and retain sample testing were performed on the batch number provided.The results were acceptable, and no relevant issues were found.No photos or samples were received; therefore, return sample analysis could not be performed.The reported issue was unable to be confirmed.Quality will continue to monitor for trends for discrepant result.It is advised not to re-insert test cartridges, and if a retest is desired, to use a new test cartridge.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, one (1) group strep a negative patient result was obtained from a veritor analyzer.The same patient test cartridge was re-inserted back into a veritor analyzer and a group strep a positive result was obtained.No confirmatory testing was reported.It should be noted the action of reinserting a used test cartridge is considered off-label use of the product.The physician treated the patient based on symptoms and no health impact or consequences were 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 ; 4103164000
• MDR Report Key: 24499882
• Report Number: 3006948883-2026-00181
• Device Sequence Number: 13251831
• Product Code: GTY
• UDI-Device Identifier: 00382902560401
• UDI-Public: (01)00382902560401(17)280109(10)5058322
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 03/27/2026

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: 5058322
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2025
• 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