BD VERITOR¿ PLUS ANALYZER
Received Mar 20, 2026 · Event occurred Feb 12, 2026
Report 1119779-2026-00441 · MDR key 24656487
Device
Generic name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Manufacturer
Becton, Dickinson & Co. (sparks)Catalog number
256066
Product problems
- False Negative Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
REPORT 1 OF 2 IT WAS REPORTED WHILE USING THE BD VERITOR¿ PLUS ANALYZER, ONE (1) NEGATIVE PATIENT RESULT WAS OBTAINED. THE SAME TEST CARTRIDGE WAS REINSERTED INTO A DIFFERENT VERITOR ANALYZER WHICH PROVIDED A POSITIVE RESULT. IN ADDITION, THE PATIENT SAMPLE WAS SENT TO A DIFFERENT LAB AND CONFIRMED TO BE POSITIVE BY AN UNKNOWN TEST METHODOLOGY. THE CUSTOMER IS ABLE TO PROVIDE THAT THE ASSAY TESTED WAS INFLUENZA RAPID DETECTION OF FLU A AND B; HOWEVER, A CATALOG NUMBER IS UNABLE TO BE PROVIDED. IT IS NOTED THAT AN ADDITIONAL SWAB WAS NOT COLLECTED FOR RETESTING AND THE CUSTOMER DID NOT SPECIFY IF THE ANALYTE IN QUESTION WAS FLU A OR FLU B. IT SHOULD ALSO BE NOTED THAT REINSERTING A USED TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
THE REQUESTED 510K INFORMATION FOR THE INVOLVED VERITOR ASSAY IS AS FOLLOWS: G4. PMA/510(K)#: CUSTOMER COULD NOT PROVIDE THE ASSAY MEDICAL DEVICE CATALOG # TO DETERMINE THE 510K. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.