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	01/26/2026
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) negative group a strep patient result was obtained from a veritor analyzer.However, the user questioned the analyzer result after visually observing lines on the test cartridge and interpreted the lines as positive for group a strep.No confirmatory or repeat testing were performed.There were no health impact or consequences reported.It should be noted the action of visual interpretation of a test cartridge is considered off-label use of the product.
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) negative group a strep patient result was obtained from a veritor analyzer.However, the user questioned the analyzer result after visually observing lines on the test cartridge and interpreted the lines as positive for group a strep.No confirmatory or repeat testing were performed.There were no health impact or consequences reported.It should be noted the action of visual interpretation of a test cartridge is considered off-label use of the product.
Additional Manufacturer Narrative
The following fields have been updated with additional information: d9.Device available for eval- yes.D9.Returned to manufacturer on: 30-jan-2026.H3.Device eval by manufacturer- yes.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 5149611.The customer reported that they are receiving negative results on the analyzer, but are seeing positive lines on the cartridge for 3 patient samples.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.Photos and return samples were received.There were several photos received, showing kit box information and used test cartridges.From the photo provided showing the test cartridge, it displays a faint test line.However, it is advised that veritor tests are not meant to be determined visually, and that the analyzer is required to interpret the results.The return samples were tested and results were passing and acceptable.The reported issue was unable to be confirmed.Quality will continue to monitor for trends with discrepant results.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: 24406076
• Report Number: 3006948883-2026-00156
• Device Sequence Number: 9905161
• Product Code: GTY
• UDI-Device Identifier: 00382902560401
• UDI-Public: (01)00382902560401(17)280210(10)5149611
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/18/2026

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: 5149611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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