MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT; ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C

Catalog Number	256045
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: this statement is to summarize the investigation results regarding the complaint that involving kit flu a+b 30 test physician veritor.The customer reported that the black spots were found when reagents were dropped in the reading area, which causing abnormal readings.Bd quality performs a systematic approach to investigate all complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.Bhr (batch history review) analysis and retain sample testing were performed on the batch number provided.The results were acceptable, and no relevant issues were found.The customer has provided a photograph confirming black spot in the test window of cartridge.Additionally, another photograph of veritor flu test result taken with a veritor reader was provided by the customer.The test result indicated a positive for flu a, but the pcr result was negative.This complaint was confirmed based on the photographic evidence.The root cause could not be determined.A trend analysis for false positive and contamination / foreign matter was conducted, no adverse trend was identified.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.This mdr is being submitted as part of a retrospective review of records dating april 2023-2025, under capa: 11910483.
Event or Problem Description
It was reported while using bd veritor¿ system for rapid detection of flu a+b clia-waved kit, contamination on the test device led to a false positive result.There was no report of patient impact.

• Brand Name: BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
• Common Device Name: ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C
• 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: 22894416
• Report Number: 3006948883-2025-00541
• Device Sequence Number: 8851940
• Product Code: GNX
• UDI-Device Identifier: 00382902560456
• UDI-Public: (01)00382902560456(11)230522(17)251205(10)3142973
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K132692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2025

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 Expiration Date: 12/05/2025
• Device Catalogue Number: 256045
• Device Lot Number: 3142973
• 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: 07/25/2023
• Initial Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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