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 Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event is unknown.The date received by manufacturer has been used for this field.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 a bd veritor¿ system for rapid detection of group a strep clia-waived kit, one (1) false positive group a strep patient result was obtained.Upon performing culture testing, a negative group a strep result was obtained.There were no health impact or consequences reported.The customer has not responded to multiple follow up attempts by bd for additional information.This is report 41 of 50.
Event or Problem Description
It was reported while using a bd veritor¿ system for rapid detection of group a strep clia-waived kit, one (1) false positive group a strep patient result was obtained.Upon performing culture testing, a negative group a strep result was obtained.There were no health impact or consequences reported.The customer has not responded to multiple follow up attempts by bd for additional information.This is report 41 of 50.
Additional Manufacturer Narrative
Investigation summary - this statement summarizes the investigation results regarding a complaint that alleges false positive when using kit grp a strep 30 test veritor (material#: 256040), batch number 5142426.The customer reported that they received 50 false positive results with the veritor kit.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 trends for false positive.There were no corrective actions taken at this time.

• 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: 24303309
• Report Number: 3006948883-2026-00120
• Device Sequence Number: 20162375
• Product Code: GTY
• UDI-Device Identifier: 00382902560401
• UDI-Public: (01)00382902560401(17)270928(10)5142426
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/07/2026

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: 5142426
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 04/07/2026
• 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