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	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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) flu b positive patient result was obtained from a veritor analyzer.It was noted the user immediately re-inserted the same cartridge back into a veritor analyzer and a flu b negative result was obtained.The patient sample was also tested using molecular platforms (liat roche and diasorian), and each provided a flu b negative result.It should be noted the action of reinserting a used test cartridge is considered off-label use of the product.There were no health impact or consequences reported.
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 3275828.The customer reported that they received two positive flu b results for patient samples, but when re-inserted right away, the results are negative.They confirmed that they tested the same samples on a molecular platform, and received flu b negative 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 photos were received.In addition, no samples were received within 30 calendar days from complaint open date; therefore, return sample analysis could not be performed.The investigation will be closed based on the information available to date.If samples are received later, the complaint may be reopened.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.
Event or Problem Description
It was reported while using the bd veritor¿ system for rapid detection of flu a+b laboratory kit, one (1) flu b positive patient result was obtained from a veritor analyzer.It was noted the user immediately re-inserted the same cartridge back into a veritor analyzer and a flu b negative result was obtained.The patient sample was also tested using molecular platforms (liat roche and diasorian), and each provided a flu b negative result.It should be noted the action of reinserting a used test cartridge is considered off-label use of the product.There were no health impact or consequences reported.

• 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: 24500984
• Report Number: 3006948883-2026-00183
• Device Sequence Number: 18789929
• Product Code: PSZ
• UDI-Device Identifier: 00382902560418
• UDI-Public: (01)00382902560418(17)260711(10)3275828
• 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): 03/31/2026

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 Expiration Date: 07/11/2026
• Device Catalogue Number: 256041
• Device Lot Number: 3275828
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2023
• 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