MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD VERITOR¿ PLUS ANALYZER; COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE

Catalog Number	256066
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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¿ plus analyzer, an unspecified number of false positive flu a+b patient results were obtained.The same patient samples were retested using different veritor analyzers, which were noted to be functioning normally.There were no health impact or consequences reported.No additional information was provided from the customer after several follow up attempts by bd.
Additional Manufacturer Narrative
The following fields have been updated with additional information: d9.Device available for evaluation: yes.D9.Returned to manufacturer on: 27-feb-2026.H3.Device eval by manufacturer?: yes.The requested 510k information for the involved veritor assay is as follows: g4.Pma/510(k)#: customer could not provide the assay to determine the 510k.Investigation summary: the complaint alleges the bd veritor plus analyzer was having a false positive issue (catalog number 256066, serial number (b)(6)).Customer provided feedback that they were running flu on eight analyzers in their department, and only one analyzer was showing positive results for all the samples.A replacement analyzer was provided to the customer.Bd veritor plus analyzer was returned for investigation.From the csv file, it appears that about seven tests were run within roughly three minutes.Three results included flu a positive flu b negative results, and the remaining four results were negative for both flu a and flu b.This pattern suggests that the samples may not have been incubated long enough before testing.When incubation is too short, the test can start developing outside the analyzer, which may lead to false positive results.Thus, this is not true instrument failure.This complaint is not confirmed.Device history record review for veritor plus analyzer, serial number (b)(6) was reviewed and nonconformances related to this failure mode were not revealed in manufacturing during final testing.The device was released conforming.Review of risk management files confirms there are no new or modified risks associated with this failure mode.Bd quality will continue to monitor for trends associated with the failure mode described in this complaint.
Event or Problem Description
It was reported while using the bd veritor¿ plus analyzer, an unspecified number of false positive flu a+b patient results were obtained.The same patient samples were retested using different veritor analyzers, which were noted to be functioning normally.There were no health impact or consequences reported.No additional information was provided from the customer after several follow up attempts by bd.

• Brand Name: BD VERITOR¿ PLUS ANALYZER
• Common Device Name: COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 23750976
• Report Number: 1119779-2025-05484
• Device Sequence Number: 15832983
• Product Code: JJQ
• UDI-Device Identifier: 00382902560661
• UDI-Public: (01)00382902560661
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.11
• 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): 02/27/2026

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: 256066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• 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