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	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G5.Additional 510k: k132259, k132692, k151291, k152870, k160161.Investigation summary: this statement summarizes the investigation results regarding a complaint that alleges false positives when using kit flu a+b 30 test physician veritor (material#: 256045), batch number 3312497.The customer reported that they received dual flu a and flu b positive results and flu b false positive results.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 return samples were received; therefore, no return sample analysis could be performed.The returned photograph only provided the kit batch information.However, a supplemental testing was performed and indicated that the reported issue may occur when using the swab used in the panbio¿ covid-19 ag test.The reported issue was confirmed based on the supplemental test.The root cause could not be determined.A trend analysis for false positive was conducted, no adverse trend was identified.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 when using the bd veritor¿ system for rapid detection of flu a+b clia-waved kit, the customer used off label panbio¿ covid-19 ag test swabs for sample collection, which resulted in false positive results.Upon confirmatory testing using pcr, the results were negative.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: 22950022
• Report Number: 3006948883-2025-00626
• Device Sequence Number: 15831473
• Product Code: PSZ
• UDI-Device Identifier: 00382902560456
• UDI-Public: (01)00382902560456(11)231108(17)261025(10)3312497
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K112277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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 Catalogue Number: 256045
• Device Lot Number: 3312497
• 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: 05/16/2024
• Initial Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2023
• 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