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

Catalog Number	256045
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	01/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd veritor¿ system for rapid detection of flu a+b clia-waived kit, the customer obtained one (1) erroneous patient result.Per the customer, a positive result was expected as the patient was symptomatic; however, the result was considered inconclusive as the testing line was not in the correct spot.Sample recollection and retesting occurred.There was no report of performing confirmatory testing.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.The customer did not specify if the analyte in question was flu a or flu b and no additional information was provided from the customer after several follow up attempts by bd.
Additional Manufacturer Narrative
The information for the additional 510k is as follows: g4.Pma/510(k)#: k132259;k132692;k151291;k152870;k160161;k180438;k223016;k232434.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary - this statement summarizes the investigation results regarding a complaint that alleges result (erroneous result) when using kit flu a+b 30 test physician veritor (material#: 256045), batch number 4289342.The customer reported that they received three erroneous results with the same patient.They were expecting to obtain a positive result, and are reporting that the line on the cartridge is not in the correct spot.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 samples were received; therefore, return sample analysis could not be performed.There were 5 photos received, showing the analyzer serial number information, three used test cartridges, and the kit box information.The photo of the three test cartridges shows 2 lines: a control line and a faint negative control (nc) line.The nc line, which is unmarked on the cartridge, functions to bind with interfering antibodies that may be present in a sample and will reduce the chances of these interfering bodies to bind to the other test lines.Since the positive control (c) line is visible in the photo received, the tests are valid and the assay is therefore functioning as expected.However, the issue reported cannot be confirmed through this image alone, without analyzer data.The reported issue was unable to be confirmed.Quality will continue to monitor for trends with result (erroneous result).Based on the testing performed, the reported issue may be a sample issue and it is recommended that the customer use a different testing methodology if this issue reoccurs.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 flu a+b clia-waived kit, the customer obtained one (1) erroneous patient result.Per the customer, a positive result was expected as the patient was symptomatic; however, the result was considered inconclusive as the testing line was not in the correct spot.Sample recollection and retesting occurred.There was no report of performing confirmatory testing.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.The customer did not specify if the analyte in question was flu a or flu b and no additional information was provided from the customer after several follow up attempts by bd.

• Brand Name: BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
• Common Device Name: DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS
• 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: 24298531
• Report Number: 3006948883-2026-00077
• Device Sequence Number: 13106687
• Product Code: PSZ
• UDI-Device Identifier: 00382902560456
• UDI-Public: (01)00382902560456(17)271007(10)4289342
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: 256045
• Device Lot Number: 4289342
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• 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