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

Catalog Number	256041
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.The information for the additional 510k is as follows: g4.Pma/510(k)#: k121797, k132256, k132693, k133138, k151301, k152874, k160164.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 flu a+b laboratory kit, one (1) false positive flu result was obtained.Upon repeat testing using a new test cartridge, a negative flu result was obtained.In addition, confirmatory molecular testing provided a negative flu result.There were no health impact or consequences reported.The user 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.This is report 2 of 10.
Event or Problem Description
It was reported while using the bd veritor¿ system for rapid detection of flu a+b laboratory kit, one (1) false positive flu result was obtained.Upon repeat testing using a new test cartridge, a negative flu result was obtained.In addition, confirmatory molecular testing provided a negative flu result.There were no health impact or consequences reported.The user 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.This is report 2 of 10.
Additional Manufacturer Narrative
Investigation summary - this statement summarizes the investigation results regarding a complaint that alleges false positive when using kit flu a+b 30 test hospital veritor (material#: 256041), batch number unknown.The customer reported that they received false positive results with 10 patient samples; they reported initially receiving a positive result, then a negative result when repeating the test with a new cartridge.They also performed confirmatory molecular testing on the 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 not performed as there was no batch number provided.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 for trends for false positive.There were no corrective actions taken at this time.

• Brand Name: BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY 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: 24429720
• Report Number: 3006948883-2026-00160
• Device Sequence Number: 10393255
• Product Code: PSZ
• UDI-Device Identifier: 00382902560418
• UDI-Public: (01)00382902560418
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120049
• 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): 04/13/2026

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: 256041
• Device Lot Number: UNKNOWN
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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